CA3152296A1 - Adjustable intraocular lenses and methods of post-operatively adjusting intraocular lenses - Google Patents
Adjustable intraocular lenses and methods of post-operatively adjusting intraocular lenses Download PDFInfo
- Publication number
- CA3152296A1 CA3152296A1 CA3152296A CA3152296A CA3152296A1 CA 3152296 A1 CA3152296 A1 CA 3152296A1 CA 3152296 A CA3152296 A CA 3152296A CA 3152296 A CA3152296 A CA 3152296A CA 3152296 A1 CA3152296 A1 CA 3152296A1
- Authority
- CA
- Canada
- Prior art keywords
- haptic
- optic
- composite material
- fluid
- intraocular lens
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
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Classifications
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A61F2250/0003—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having an inflatable pocket filled with fluid, e.g. liquid or gas
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- A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
- A61L2300/204—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials with nitrogen-containing functional groups, e.g. aminoxides, nitriles, guanidines
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- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
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- A61L2430/00—Materials or treatment for tissue regeneration
- A61L2430/16—Materials or treatment for tissue regeneration for reconstruction of eye parts, e.g. intraocular lens, cornea
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Abstract
Disclosed are adjustable accommodating intraocular lenses and methods of adjusting accommodating intraocular lenses post-operatively. In one embodiment, an adjustable accommodating intraocular lens comprises an optic portion and a peripheral portion. At least one of the optic portion and the peripheral portion can be made in part of a composite material comprising an energy absorbing constituent and a plurality of expandable components. At least one of a base power and a cylindricity of the optic portion can be configured to change in response to an external energy directed at the composite material.
Description
2 ADJUSTABLE INTRAOCULAR LENSES AND METHODS OF
3 POST-OPERATIVELY ADJUSTING INTRAOCULAR LENSES
4 CROSS-REFERENCE TO RELATED APPLICATION
6 [00011 This application claims the benefit of U.S. Provisional Application No. 62/911,039 7 filed on October 4, 2019, the entirety of which is incorporated herein by reference.
[0002] The present disclosure relates generally to the field of intraocular lenses, and, more 11 specifically, to adjustable intraocular lenses and methods of adjusting intraocular lenses 14 [0003] A cataract is a condition involving the clouding over of the normally clear lens of a patient's eye. Cataracts occur as a result of aging, hereditary factors, trauma, inflammation, 16 metabolic disorders, or exposure to radiation. Age-related cataract is the most common type of 17 cataracts. In treating a cataract, the surgeon removes the crystalline lens matrix from the 18 patient's lens capsule and replaces it with an intraocular lens (IOL).
Traditional IOLs provide 19 one or more selected focal lengths that allow the patient to have distance vision. However, after cataract surgery, patients with traditional IOLs often require glasses or other corrective 21 eyewear for certain activities since the eye can no longer undertake accommodation (or change 22 its optical power) to maintain a clear image of an object or focus on an object as its distance 23 varies.
24 [0004] Newer IOLs such as accommodating IOLs, allow the eye to regain at least some focusing ability. Accommodating IOLs (AIOLs) use forces available in the eye to change 26 some portion of the optical system in order to refocus the eye on distant or near targets.
27 Examples of AIOLs are discussed in the following U.S. patent publications: U.S. Pat. Pub. No.
28 2018/0256315; U.S. Pat. Pub. No. 2018/0153682; and U.S. Pat. Pub. No.
2017/0049561 and in 29 the following issued U.S. patents: U.S. Pat. No. 10,299,913; U.S. Pat.
No. 10,195,020; and U.S. Pat. No. 8,968,396, the contents of which are incorporated herein by reference in their 31 entireties.
1 [0005] Even with AIOLs, there may be a need to adjust such lenses post-operatively or after 2 implantation within the eye of a patient. For example, once an AIOL is implanted within the 3 capsular bag, an aggressive healing response by tissue within the capsular bag can squeeze an 4 AIOL and drive the optical power higher than initially anticipated. In some cases, the pre-operative biometry measurements made on a patient's eye may be incorrect, leading to IOLs 6 with the wrong lens power being prescribed and implanted within the patient. Moreover, a 7 patient's cornea or muscles within the eye may change as a result of injury, disease, or aging.
8 In such cases, it may also be necessary to adjust the patient's implanted IOLs or AIOLs to 9 account for such changes.
[0006] Besides lower-order aberrations (such as focusing power), higher-order aberrations 11 such as cylindrical astigmatism and spherical aberration are also commonly corrected with 12 intraocular lenses. Cylindrical astigmatism is generally developed in the cornea naturally and a 13 large proportion of patients with preexisting cataracts also have some degree of astigmatism.
14 While toric IOLs have been used to correct astigmatism at the time of cataract surgery, one difficulty faced by all toric lens makers is that such lenses are rotationally asymmetric so 16 proper placement of the lens relative to a patient's own existing aberration is crucial When a 17 misplacement does occur, a patient's only recourse is often to undergo additional surgery to 18 correct for such a misplacement.
19 [0007] Therefore, a solution is needed which allows for post-implant adjustment of IOLs or AIOLs without having to undergo additional surgery. Such a solution should not overly 21 complicate the design of such lenses and still allow the lenses to be cost-effectively 22 manufactured.
[0008] Disclosed herein are adjustable intraocular lenses, adjustable accommodating 26 intraocular lenses, and methods of adjusting intraocular lenses and accommodating intraocular 27 lenses. In one embodiment, an adjustable accommodating intraocular lens is disclosed 28 comprising an optic portion comprising an anterior element and a posterior element. The 29 anterior element can comprise an anterior optical surface. The posterior element can comprise a posterior optical surface. A fluid-filled optic fluid chamber can be defined in between the 31 anterior element and the posterior element.
1 [0009] The optic portion can have a base power or base spherical power.
The base power of 2 the optic portion can be configured to change based on an internal fluid pressure within the 3 fluid-filled optic fluid chamber. The base power of the optic portion can be configured to 4 increase or decrease as fluid enters or exits the optic fluid chamber.
The optic portion can be configured to change shape in response to fluid entering or exiting the optic fluid chamber. In 6 certain embodiments, the anterior element of the optic portion can be configured to change 7 shape in response to the fluid entering or exiting the optic fluid chamber. In other 8 embodiments, the posterior element of the optic portion can be configured to change shape in 9 response to the fluid entering or exiting the optic fluid chamber. In further embodiments, both the anterior element and the posterior element of the optic portion can be configured to change 11 shape in response to the fluid entering or exiting the optic fluid chamber.
12 [0010] The base power of the optic portion can be configured to change in response to the 13 shape change undertaken by the shape-changing optic portion (e.g., the anterior element, the 14 posterior element, or a combination thereof). The shape-changing optic portion can be configured to change shape in response to a physiologic muscle movement (e.g., ciliary 16 muscle movement) undertaken by a patient when the adjustable accommodating intraocular 17 lens is implanted within an eye of the patient.
18 [0011] In some embodiments, the adjustable accommodating intraocular lens can comprise 19 one or more haptics coupled to and extending from the optic portion.
Each of the one or more haptics can comprise a haptic fluid chamber within the haptic. The base power of the optic 21 portion can be configured to increase as fluid enters the optic fluid chamber from the haptic 22 fluid chamber(s). The base power of the optic portion can be configured to decrease as fluid 23 exits or is drawn out of the optic fluid chamber into the haptic fluid chamber(s).
24 [0012] The optic fluid chamber can be in fluid communication with or fluidly connected to the haptic fluid chamber(s). The optic fluid chamber can be in fluid communication with a haptic 26 fluid chamber through a pair of fluid channels. The fluid channels can be conduits or 27 passageways fluidly connecting the optic fluid chamber to the haptic fluid chamber. The pair 28 of fluid channels can be spaced apart from one another. For example, the pair of fluid channels 29 can be spaced apart between about 0.1 mm to about 1.0 mm.
1 [0013] In some embodiments, the pair of fluid channels can be defined and extend through 2 part of the optic portion. More specifically, the pair of fluid channels can be defined and 3 extend through the posterior element.
4 [0014] The one or more haptics can be coupled to the optic portion at a haptic-optic interface.
The one or more haptics can be coupled to the optic portion at a reinforced portion along the 6 optic portion. The reinforced portion can be part of the haptic-optic interface. The pair of fluid 7 channels can be defined or formed within part of the reinforced portion.
8 [0015] In some embodiments, the adjustable accommodating intraocular lens can comprise 9 two haptics coupled to and extending from the optic portion. The first haptic can comprise a first haptic fluid chamber within the first haptic. The second haptic can comprise a second 11 haptic fluid chamber within the second haptic. The first haptic can be coupled to the optic 12 portion at a first haptic-optic interface and the second haptic can be coupled to the optic 13 portion at a second haptic-optic interface.
14 [0016] In these embodiments, the optic fluid chamber can be in fluid communication with both the first haptic fluid chamber and the second haptic fluid chamber. The optic fluid 16 chamber can be in fluid communication with the first haptic fluid chamber through a first pair 17 of fluid channels. The optic fluid chamber can be in fluid communication with the second 18 haptic fluid chamber through a second pair of fluid channels.
19 [0017] The first pair of fluid channels can be spaced apart from one another. The first pair of fluid channels can be spaced apart between about 0.1 mm to about 1.0 mm. The second pair of 21 fluid channels can be spaced apart from one another. The second pair of fluid channels can be 22 spaced apart between about 0.1 mm to about 1.0 mm.
23 [0018] The first pair of fluid channels and the second pair of fluid channels can be defined and 24 extend through part of the optic portion. The first pair of fluid channels and the second pair of fluid channels can be defined and extend through the posterior element.
26 [0019] The optic portion can also comprise a first reinforced portion and a second reinforced 27 portion substantially on opposing sides of the optic portion or substantially diametrically 28 opposed to one another. The first pair of fluid channels can be defined or formed within the 29 first reinforced portion. The second pair of fluid channels can be defined or formed within the second reinforced portion.
1 [0020] The first pair of fluid channels can terminate at a first pair of apertures defined within 2 the optic portion. The first pair of fluid channels can terminate at a first pair of apertures 3 defined within the posterior element. The first pair of apertures can be spaced apart between 4 about 0.1 mm to about 1.0 mm. The second pair of fluid channels can terminate at a second pair of apertures defined within the optic portion. The second pair of fluid channels can 6 terminate at a second pair of apertures within the posterior element. The second pair of 7 apertures can be spaced apart between about 0.1 mm to about 1.0 mm.
8 [0021] In some embodiments, the first pair of fluid channels and the second pair of fluid 9 channels can be positioned substantially on opposite sides of the optic portion. The first pair of fluid channels can be positioned substantially diametrically opposed to the second pair of fluid 11 channels.
12 [0022] In these embodiments, the first pair of apertures and the second pair of apertures can be 13 positioned substantially on opposite sides of the optic portion. The first pair of apertures can 14 be positioned substantially diametrically opposed to the second pair of apertures.
[0023] In some embodiments, at least one of the optic portion and the peripheral portion (e.g., 16 the haptics) can be made in part of a cross-linked copolymer comprising a copolymer blend.
17 Moreover, at least one of the optic portion and the peripheral portion can be made in part of a 18 composite material comprising an energy absorbing constituent, a plurality of expandable 19 components, and a composite base material made in part of the copolymer blend. At least one of a base power and a cylindricity of the optic portion can be configured to change in response 21 to an external energy directed at the composite material.
22 [0024] In certain embodiments, the adjustable accommodating intraocular lens can be 23 implanted within an eye of a subject. At least one of the base power and the cylindricity of the 24 optic portion can be configured to change in response to the external energy directed at the composite material when the adjustable accommodating intraocular lens is implanted within an 26 eye of the subject.
27 [0025] In some embodiments, the expandable components can be expandable microspheres 28 comprising a blowing agent within expandable thermoplastic shells. The blowing agent can be 29 a branched-chain hydrocarbon. For example, the branched-chain hydrocarbon can be isopentane.
6 [00011 This application claims the benefit of U.S. Provisional Application No. 62/911,039 7 filed on October 4, 2019, the entirety of which is incorporated herein by reference.
[0002] The present disclosure relates generally to the field of intraocular lenses, and, more 11 specifically, to adjustable intraocular lenses and methods of adjusting intraocular lenses 14 [0003] A cataract is a condition involving the clouding over of the normally clear lens of a patient's eye. Cataracts occur as a result of aging, hereditary factors, trauma, inflammation, 16 metabolic disorders, or exposure to radiation. Age-related cataract is the most common type of 17 cataracts. In treating a cataract, the surgeon removes the crystalline lens matrix from the 18 patient's lens capsule and replaces it with an intraocular lens (IOL).
Traditional IOLs provide 19 one or more selected focal lengths that allow the patient to have distance vision. However, after cataract surgery, patients with traditional IOLs often require glasses or other corrective 21 eyewear for certain activities since the eye can no longer undertake accommodation (or change 22 its optical power) to maintain a clear image of an object or focus on an object as its distance 23 varies.
24 [0004] Newer IOLs such as accommodating IOLs, allow the eye to regain at least some focusing ability. Accommodating IOLs (AIOLs) use forces available in the eye to change 26 some portion of the optical system in order to refocus the eye on distant or near targets.
27 Examples of AIOLs are discussed in the following U.S. patent publications: U.S. Pat. Pub. No.
28 2018/0256315; U.S. Pat. Pub. No. 2018/0153682; and U.S. Pat. Pub. No.
2017/0049561 and in 29 the following issued U.S. patents: U.S. Pat. No. 10,299,913; U.S. Pat.
No. 10,195,020; and U.S. Pat. No. 8,968,396, the contents of which are incorporated herein by reference in their 31 entireties.
1 [0005] Even with AIOLs, there may be a need to adjust such lenses post-operatively or after 2 implantation within the eye of a patient. For example, once an AIOL is implanted within the 3 capsular bag, an aggressive healing response by tissue within the capsular bag can squeeze an 4 AIOL and drive the optical power higher than initially anticipated. In some cases, the pre-operative biometry measurements made on a patient's eye may be incorrect, leading to IOLs 6 with the wrong lens power being prescribed and implanted within the patient. Moreover, a 7 patient's cornea or muscles within the eye may change as a result of injury, disease, or aging.
8 In such cases, it may also be necessary to adjust the patient's implanted IOLs or AIOLs to 9 account for such changes.
[0006] Besides lower-order aberrations (such as focusing power), higher-order aberrations 11 such as cylindrical astigmatism and spherical aberration are also commonly corrected with 12 intraocular lenses. Cylindrical astigmatism is generally developed in the cornea naturally and a 13 large proportion of patients with preexisting cataracts also have some degree of astigmatism.
14 While toric IOLs have been used to correct astigmatism at the time of cataract surgery, one difficulty faced by all toric lens makers is that such lenses are rotationally asymmetric so 16 proper placement of the lens relative to a patient's own existing aberration is crucial When a 17 misplacement does occur, a patient's only recourse is often to undergo additional surgery to 18 correct for such a misplacement.
19 [0007] Therefore, a solution is needed which allows for post-implant adjustment of IOLs or AIOLs without having to undergo additional surgery. Such a solution should not overly 21 complicate the design of such lenses and still allow the lenses to be cost-effectively 22 manufactured.
[0008] Disclosed herein are adjustable intraocular lenses, adjustable accommodating 26 intraocular lenses, and methods of adjusting intraocular lenses and accommodating intraocular 27 lenses. In one embodiment, an adjustable accommodating intraocular lens is disclosed 28 comprising an optic portion comprising an anterior element and a posterior element. The 29 anterior element can comprise an anterior optical surface. The posterior element can comprise a posterior optical surface. A fluid-filled optic fluid chamber can be defined in between the 31 anterior element and the posterior element.
1 [0009] The optic portion can have a base power or base spherical power.
The base power of 2 the optic portion can be configured to change based on an internal fluid pressure within the 3 fluid-filled optic fluid chamber. The base power of the optic portion can be configured to 4 increase or decrease as fluid enters or exits the optic fluid chamber.
The optic portion can be configured to change shape in response to fluid entering or exiting the optic fluid chamber. In 6 certain embodiments, the anterior element of the optic portion can be configured to change 7 shape in response to the fluid entering or exiting the optic fluid chamber. In other 8 embodiments, the posterior element of the optic portion can be configured to change shape in 9 response to the fluid entering or exiting the optic fluid chamber. In further embodiments, both the anterior element and the posterior element of the optic portion can be configured to change 11 shape in response to the fluid entering or exiting the optic fluid chamber.
12 [0010] The base power of the optic portion can be configured to change in response to the 13 shape change undertaken by the shape-changing optic portion (e.g., the anterior element, the 14 posterior element, or a combination thereof). The shape-changing optic portion can be configured to change shape in response to a physiologic muscle movement (e.g., ciliary 16 muscle movement) undertaken by a patient when the adjustable accommodating intraocular 17 lens is implanted within an eye of the patient.
18 [0011] In some embodiments, the adjustable accommodating intraocular lens can comprise 19 one or more haptics coupled to and extending from the optic portion.
Each of the one or more haptics can comprise a haptic fluid chamber within the haptic. The base power of the optic 21 portion can be configured to increase as fluid enters the optic fluid chamber from the haptic 22 fluid chamber(s). The base power of the optic portion can be configured to decrease as fluid 23 exits or is drawn out of the optic fluid chamber into the haptic fluid chamber(s).
24 [0012] The optic fluid chamber can be in fluid communication with or fluidly connected to the haptic fluid chamber(s). The optic fluid chamber can be in fluid communication with a haptic 26 fluid chamber through a pair of fluid channels. The fluid channels can be conduits or 27 passageways fluidly connecting the optic fluid chamber to the haptic fluid chamber. The pair 28 of fluid channels can be spaced apart from one another. For example, the pair of fluid channels 29 can be spaced apart between about 0.1 mm to about 1.0 mm.
1 [0013] In some embodiments, the pair of fluid channels can be defined and extend through 2 part of the optic portion. More specifically, the pair of fluid channels can be defined and 3 extend through the posterior element.
4 [0014] The one or more haptics can be coupled to the optic portion at a haptic-optic interface.
The one or more haptics can be coupled to the optic portion at a reinforced portion along the 6 optic portion. The reinforced portion can be part of the haptic-optic interface. The pair of fluid 7 channels can be defined or formed within part of the reinforced portion.
8 [0015] In some embodiments, the adjustable accommodating intraocular lens can comprise 9 two haptics coupled to and extending from the optic portion. The first haptic can comprise a first haptic fluid chamber within the first haptic. The second haptic can comprise a second 11 haptic fluid chamber within the second haptic. The first haptic can be coupled to the optic 12 portion at a first haptic-optic interface and the second haptic can be coupled to the optic 13 portion at a second haptic-optic interface.
14 [0016] In these embodiments, the optic fluid chamber can be in fluid communication with both the first haptic fluid chamber and the second haptic fluid chamber. The optic fluid 16 chamber can be in fluid communication with the first haptic fluid chamber through a first pair 17 of fluid channels. The optic fluid chamber can be in fluid communication with the second 18 haptic fluid chamber through a second pair of fluid channels.
19 [0017] The first pair of fluid channels can be spaced apart from one another. The first pair of fluid channels can be spaced apart between about 0.1 mm to about 1.0 mm. The second pair of 21 fluid channels can be spaced apart from one another. The second pair of fluid channels can be 22 spaced apart between about 0.1 mm to about 1.0 mm.
23 [0018] The first pair of fluid channels and the second pair of fluid channels can be defined and 24 extend through part of the optic portion. The first pair of fluid channels and the second pair of fluid channels can be defined and extend through the posterior element.
26 [0019] The optic portion can also comprise a first reinforced portion and a second reinforced 27 portion substantially on opposing sides of the optic portion or substantially diametrically 28 opposed to one another. The first pair of fluid channels can be defined or formed within the 29 first reinforced portion. The second pair of fluid channels can be defined or formed within the second reinforced portion.
1 [0020] The first pair of fluid channels can terminate at a first pair of apertures defined within 2 the optic portion. The first pair of fluid channels can terminate at a first pair of apertures 3 defined within the posterior element. The first pair of apertures can be spaced apart between 4 about 0.1 mm to about 1.0 mm. The second pair of fluid channels can terminate at a second pair of apertures defined within the optic portion. The second pair of fluid channels can 6 terminate at a second pair of apertures within the posterior element. The second pair of 7 apertures can be spaced apart between about 0.1 mm to about 1.0 mm.
8 [0021] In some embodiments, the first pair of fluid channels and the second pair of fluid 9 channels can be positioned substantially on opposite sides of the optic portion. The first pair of fluid channels can be positioned substantially diametrically opposed to the second pair of fluid 11 channels.
12 [0022] In these embodiments, the first pair of apertures and the second pair of apertures can be 13 positioned substantially on opposite sides of the optic portion. The first pair of apertures can 14 be positioned substantially diametrically opposed to the second pair of apertures.
[0023] In some embodiments, at least one of the optic portion and the peripheral portion (e.g., 16 the haptics) can be made in part of a cross-linked copolymer comprising a copolymer blend.
17 Moreover, at least one of the optic portion and the peripheral portion can be made in part of a 18 composite material comprising an energy absorbing constituent, a plurality of expandable 19 components, and a composite base material made in part of the copolymer blend. At least one of a base power and a cylindricity of the optic portion can be configured to change in response 21 to an external energy directed at the composite material.
22 [0024] In certain embodiments, the adjustable accommodating intraocular lens can be 23 implanted within an eye of a subject. At least one of the base power and the cylindricity of the 24 optic portion can be configured to change in response to the external energy directed at the composite material when the adjustable accommodating intraocular lens is implanted within an 26 eye of the subject.
27 [0025] In some embodiments, the expandable components can be expandable microspheres 28 comprising a blowing agent within expandable thermoplastic shells. The blowing agent can be 29 a branched-chain hydrocarbon. For example, the branched-chain hydrocarbon can be isopentane.
5 1 [0026] The thickness of the thermoplastic shells can be configured to change in response to 2 the external energy directed at the composite material. In some embodiments, the 3 thermoplastic shells can be made in part of an acrylonitrile copolymer.
4 [00271 A diameter of at least one of the expandable microspheres can be configured to increase between about two times (2X) to about four times (4X) in response to the external
4 [00271 A diameter of at least one of the expandable microspheres can be configured to increase between about two times (2X) to about four times (4X) in response to the external
6 energy directed at the composite material. A volume of at least one of the expandable
7 microspheres can be configured to expand between about ten times (10X) to about fifty times
8 (50X) in response to the external energy directed at the composite material.
9 [0028] The expandable components can comprise between about 5% to about 15% (more specifically, about 8% to about 12%) by weight of the composite material. For example, the 11 expandable components can comprise about 10% by weight of the composite material.
12 [0029] The energy absorbing constituent can comprise between about 0.025% to about 1.0%
13 (or, more specifically, about 0.045% to about 0.45%) by weight of the composite material. In 14 some embodiments, the energy absorbing constituent can be an energy absorbing colorant. For example, a color of the energy absorbing colorant can be visually perceptible to a clinician or 16 another medical professional when the acconunodating intraocular lens is implanted within an 17 eye.
18 [0030] The energy absorbing colorant can be a dye. For example, the dye can be an azo dye. In 19 some embodiments, the dye can be a red azo dye such as Disperse Red 1 dye. The energy absorbing colorant can also comprise a pigment. For example, the pigment can be graphitized 21 carbon black.
22 [0031] In some embodiments, at least one of the optic portion and the peripheral portion can 23 be made in part of a first composite material and a second composite material. The first 24 composite material can comprise a first energy absorbing colorant. The second composite material can comprise a second energy absorbing colorant. In certain embodiments, the color 26 of the first energy absorbing colorant can be different from the color of the second energy 27 absorbing colorant.
28 [0032] In addition to the copolymer blend, the composite base material can further comprise at 29 least one of one or more reactive acrylic monomer diluents, a photoinitiator, and a thermal initiator. The copolymer blend can comprise an alkyl acrylate, a fluoro-alkyl acrylate, and a 31 phenyl-alkyl acrylate. The composite material can remain relatively fixed at one or more 1 locations within the optic portion or the peripheral portion during all phases of accommodation 2 or disaccornmodation of the intraocular lens.
3 [0033] As previously discussed, the base power of the adjustable accommodating intraocular 4 lens can be configured to change in response to an external energy directed at a composite material making up at least part of the adjustable acconunodating intraocular lens. The base 6 power of the optic portion can be configured to change between about 0.05 D to about -0.5 D
7 (e.g., more specifically, between about 0.1 D to about 0.2 D) in response to pulses of the 8 external energy directed at the composite material. In some embodiments, the base power of 9 the optic portion can be configured to change by up to 2.0 D in total.
In other embodiments, the base power of the optic portion can be configured to change by up to -15.0 D in total.
11 [0034] In some embodiments, the external energy can be light energy. The external energy can 12 be light energy from a laser light. The light energy can have a wavelength between about 488 13 nm to about 650 nm. For example, the light energy can be green laser light having a 14 wavelength between about 520 nm to about 570 nm. As a more specific example, the light energy can be green laser light having a wavelength of about 532 nm.
16 [0035] The external energy directed or otherwise applied to the composite material can cause a 17 persistent change in an optical parameter of the adjustable accommodating intraocular lens.
18 For example, the external energy directed or otherwise applied to the composite material can 19 cause a persistent change in the base power of the adjustable accommodating intraocular lens.
Also, for example, the external energy directed or otherwise applied to the composite material 21 can cause a persistent change in the cylindricity of the optic portion of the adjustable 22 accommodating intraocular lens.
23 [0036] In some embodiments, the optic portion can be made in part of the composite material.
24 In these embodiments, at least one of the base power and the cylindricity of the optic portion can be configured to change in response to the external energy directed at the optic portion.
26 For example, the composite material can be located along a first peripheral edge of an anterior 27 element of the optic portion. In this example, the composite material can also be located along 28 a second peripheral edge diametrically opposed to the first peripheral edge. The cylindricity of 29 the anterior optical surface can be configured to change in response to the external energy directed at the first peripheral edge and the second peripheral edge.
1 [0037] Alternatively, the composite material can also be located along a first peripheral edge 2 along a second peripheral edge of a posterior element of the optic portion. The second 3 peripheral edge can be diametrically opposed to the first peripheral edge. The cylindricity of 4 the posterior optical surface can be configured to change in response to the external energy directed at the first peripheral edge and the second peripheral edge.
6 [0038] As previously discussed, the anterior element of the optic portion can be bonded or 7 otherwise adhered circumferentially to the posterior element by an adhesive layer. In some 8 embodiments, the adhesive layer can comprise the composite material. The base power of the 9 optic portion can be configured to decrease in response to an external energy directed at the adhesive layer. The adhesive layer can be configured to expand in response to the external 11 energy directed at the adhesive layer. Expansion of the adhesive layer can cause a volume of 12 the optic fluid chamber within the optic portion to increase. An increase in the volume of the 13 optic fluid chamber can cause an internal fluid pressure within the optic fluid chamber to 14 decrease, thereby causing the anterior element to flatten or decrease its curvature.
[0039] In other embodiments, the peripheral portion (e.g., the haptic(s)) of the adjustable 16 accommodating intraocular lens can be made in part of the composite material_ As previously 17 discussed, the peripheral portion can include at least one haptic comprising a fluid-filled haptic 18 fluid chamber in fluid communication with the optic chamber. The base power of the optic 19 portion can be configured to change in response to the external energy directed at portions of the peripheral portion made in part of the composite material. The external energy can cause 21 fluid flow or fluid displacement between the fluid-filled optic chamber and the haptic fluid 22 chamber.
23 [0040] For example, the base power can be configured to change in response to a change in 24 the volume of the haptic fluid chamber. Also, for example, the base power of the adjustable accommodating intraocular lens can be configured to change in response to an interaction 26 between the peripheral portion and a capsular environment surrounding the adjustable 27 accommodating intraocular lens when the lens is implanted within an eye.
28 [0041] More specifically, the composite material can be configured or designed as a spacer 29 extending radially from a haptic chamber wall. The spacer can be configured to expand in response to the external energy directed at the spacer. Expansion of the spacer can result in a 1 reduction of the volume of the haptic fluid chamber by pushing the haptic(s) against one or 2 more capsular bag walls.
3 [0042] The composite material can also be located partly within a haptic chamber wall 4 surrounding the haptic fluid chamber. For example, the composite material can be located at least partially within a channel formed along a radially inner wall of the haptic. A volume of 6 the haptic fluid chamber can be configured to increase in response to the external energy 7 directed at the composite material.
8 [0043] In other embodiments, the composite material can be positioned or located at least 9 partially along a radially outermost portion of a radially inner wall of the haptic. A volume of the haptic fluid chamber can be configured to decrease in response to the external energy 11 directed at the composite material. In at least some of these embodiments, the composite 12 material can expand into the haptic fluid chamber in response to the external energy directed at 13 the composite material.
14 [0044] In further embodiments, a haptic of the adjustable accommodating intraocular lens can comprise a first haptic portion and a second haptic portion. The first haptic portion and the 16 second haptic portion can be made in part of the composite material. A
base power of the optic 17 portion can be configured to increase in response to an external energy directed at the first 18 haptic portion. For example, the base power of the optic portion can be configured to increase 19 in response to fluid flowing from the haptic fluid chamber to the optic fluid chamber as a result of the external energy directed at the first haptic portion.
21 [0045] Moreover, the base power of the optic portion can be configured to decrease in 22 response to the external energy directed at the second haptic portion.
The base power of the 23 optic portion can be configured to decrease in response to fluid flowing from the optic fluid 24 chamber to the haptic fluid chamber as a result of the external energy directed at the second haptic portion. At least one of the first haptic portion and the second haptic portion can be 26 located partly within a haptic chamber wall surrounding the haptic fluid chamber.
27 [0046] hi some embodiments, the first haptic portion can be made in part of a first composite 28 material and the second haptic portion can be made in part of a second composite material.
29 The first composite material can comprise a first energy absorbing constituent and the second composite material can comprise a second energy absorbing constituent. The composition of 31 the first energy absorbing constituent can be different from the composition of the second 1 energy absorbing constituent. For example, the first energy absorbing constituent can be an 2 energy absorbing dye having a first color. In this example, the second energy absorbing 3 constituent can be another energy absorbing dye having a second color different from the first 4 color.
[0047] The first haptic portion can be radially offset from the second haptic portion. In some 6 embodiments, at least one of the first haptic portion and the second haptic portion can be 7 oriented in a pattern such that a location of the at least one of the first haptic portion and the 8 second haptic portion along the haptic is visually perceptible to a clinician or another medical 9 professional.
[0048] A method of adjusting an accommodating intraocular lens is also disclosed. The 11 method can comprise adjusting a base power of the acconunodating intraocular lens by 12 directing an external energy at a composite material within at least one of an optic portion and 13 a peripheral portion of the accommodating intraocular lens. The composite material can 14 comprise an energy absorbing constituent, a plurality of expandable components, and the composite base material made in part of the copolymer blend.
16 [0049] The method can further comprise adjusting the base power of the accommodating 17 intraocular lens when the accommodating intraocular lens is implanted within an eye of a 18 subject. The method can further comprise adjusting the cylindricity of an optical surface of the 19 optic portion of the accommodating intraocular lens by directing an external energy at the composite material arranged at diametrically opposed peripheral edges of the optic portion.
21 [0050] The method can also comprise directing the external energy at the composite material 22 to energize the energy absorbing constituent to cause thermal energy to be transferred to the 23 expandable components. In some embodiments, the plurality of expandable components can 24 be expandable microspheres comprising a blowing agent contained within thermoplastic shells. Directing the external energy at the composite material can cause the rnicrospheres to 26 expand.
27 [0051] In some embodiments, the external energy can be light energy. For example, the light 28 energy can be laser light having a wavelength between about 488 nm to about 650 nm.
29 [0052] The method can further comprise adjusting the base power of the optic portion between about 0.05 D to about 0.5 D (e.g., more specifically, between about 0.1 D
to about 0.2 D) 31 in response to pulses of the external energy directed at the composite material.
1 [0053] The method can also comprise directing the external energy at the composite material 2 to displace fluid between the optic chamber and the haptic fluid chamber.
For example, the 3 method can comprise directing the external energy at the composite material to change a 4 volume of the haptic fluid chamber. This change in the volume of the haptic fluid chamber can result in a change in the base power of the accommodating intraocular lens.
The method can 6 further comprise adjusting the base power of the accommodating intraocular lens by directing 7 the external energy at the composite material to cause a haptic of the lens to interact with a 8 capsular environment surrounding the implanted accommodating intraocular lens.
9 [0054] Moreover, the method can also comprise adjusting the base power of the accommodating intraocular lens by directing the external energy at the composite material to 11 change a volume of the optic fluid chamber. This change in the volume of the optic fluid 12 chamber can result in fluid flow out of the optical fluid chamber, thereby causing part of the 13 optic portion to change shape and the base power of the lens to decrease.
BRIEF DESCRIPTION OF THE DRAWINGS
16 [0055] Fig. lA illustrates a top plan view of an embodiment of an adjustable accommodating 17 intraocular lens.
18 [0056] Figs. 1B and 1C illustrate sectional views of an embodiment of the adjustable 19 accommodating intraocular lens.
[0057] Fig. 1D illustrates an exploded view of an embodiment of the adjustable 21 accommodating intraocular lens.
22 [0058] Fig. 2A illustrates a composite material used to make at least part of the adjustable 23 accommodating intraocular lens.
24 [0059] Fig. 2B illustrates one embodiment of an expandable component of the composite material.
26 [0060] Figs. 3A and 3B illustrate sectional views of an embodiment of the adjustable 27 accommodating intraocular lens comprising an expandable spacer.
28 [0061] Figs. 4A and 4B illustrate top and sectional views, respectively, of another embodiment 29 of the adjustable accommodating intraocular lens comprising the expandable spacer extending radially inward.
1 [0062] Figs. 5A and 5B illustrate sectional views of another embodiment of the adjustable 2 accommodating intraocular lens comprising an expandable spreader.
3 [0063] Fig. 6 illustrates a sectional view of another embodiment of the adjustable 4 accommodating intraocular lens comprising an expandable protuberance.
[0064] Figs. 7A and 7B illustrate top and sectional views, respectively, of another embodiment 6 of the adjustable acconunodating intraocular lens comprising both an expandable spreader and 7 an expandable protuberance.
8 [0065] Fig. 8 illustrates a top plan view of another embodiment of the adjustable 9 accommodating intraocular lens comprising both expandable spreaders and expandable protuberances implemented as discrete components along the haptics.
11 [0066] Fig. 9A illustrates a top plan view of another embodiment of the adjustable 12 accommodating intraocular lens comprising both expandable spreaders and expandable 13 protuberances arranged in a visually perceptible pattern.
14 [0067] Fig. 9B illustrates a sectional view of the embodiment of the adjustable accommodating intraocular lens shown in Fig. 9A taken along cross-section A-A.
16 [0068] Fig. 9C illustrates a sectional view of the embodiment of the adjustable 17 accommodating intraocular lens shown in Fig. 9A taken along cross-section B-B.
18 [0069] Fig. 10 illustrates a sectional view of an optic portion of another embodiment of the 19 adjustable accommodating intraocular lens comprising an adhesive layer made in part of the composite material.
21 [0070] Fig. 11 illustrates a perspective view of another embodiment of the adjustable 22 accommodating intraocular lens configured to exhibit cylindricity in response to an external 23 energy directed at the adjustable accommodating intraocular lens.
DETAILED DESCRIPTION
26 [0071] Fig. lA illustrates a top plan view of an embodiment of an adjustable accommodating 27 intraocular lens (AIOL) 100 for correcting defocus aberration, corneal astigmatism, spherical 28 aberration, or a combination thereof. The adjustable AIOL 100 can comprise an optic portion 29 102 and a peripheral portion 103 that, in this embodiment, comprises one or more haptics 104 including a first haptic 104A and a second haptic 104B coupled to and extending peripherally 1 from the optic portion 102. The adjustable AIOL 100 is configured to be positioned within a 2 native capsular bag in which a native lens has been removed.
3 [0072] When implanted within the native capsular bag, the optic portion 102 can be adapted to 4 refract light that enters the eye onto the retina. The peripheral portion 103 (e.g., the one or more haptics 104) can be configured to engage the capsular bag and is adapted to deform in 6 response to ciliary muscle movement (e.g., muscle relaxation, muscle contraction, or a 7 combination thereof) in connection with capsular bag reshaping.
Engagement of the peripheral 8 portion 103 (e.g., the one or more haptics 104) with the capsular bag will be discussed in more 9 detail in the following sections.
[0073] Figs. 1B and 1C illustrate sectional views of an embodiment of the adjustable AIOL
11 100 as taken along cross-section A-A of Fig. 1A. As shown in Figs. 1B
and 1C, the optic 12 portion 102 can comprise an anterior element 106 and a posterior element 108. A fluid-filled 13 optic fluid chamber 110 can be defined in between the anterior element 106 and the posterior 14 element 108.
[0074] The anterior element 106 can comprise an anterior optical surface 112 and an anterior 16 inner surface 114 opposite the anterior optical surface 112_ The posterior element 108 can 17 comprise a posterior optical surface 116 and a posterior inner surface 118 opposite the 18 posterior optical surface 116. Any of the anterior optical surface 112, the posterior optical 19 surface 116, or a combination thereof can be considered and referred to as an external optical surface. The anterior inner surface 114 and the posterior inner surface 118 can face the optic 21 fluid chamber 110. At least part of the anterior inner surface 114 and at least part of the 22 posterior inner surface 118 can serve as chamber walls of the optic fluid chamber 110.
23 [0075] Each of the one or more haptics 104 can comprise a haptic fluid chamber 120 within 24 the haptic 104. For example, the first haptic 104A can comprise a first haptic fluid chamber 120A within the first haptic 104A and the second haptic 104B can comprise a second haptic 26 fluid chamber 120B within the second haptic 104B. The haptic fluid chamber 120 (e.g., any of 27 the first haptic fluid chamber 120A, the second haptic fluid chamber 120B, or a combination 28 thereof) can be in fluid communication with or fluidly connected to the optic fluid chamber 29 110.
[0076] The optic fluid chamber 110 can be in fluid communication with the one or more 31 haptic fluid chambers 120 through a pair of fluid channels 122 (see Fig.
1A). The fluid 1 channels 122 can be conduits or passageways fluidly connecting the optic fluid chamber 110 2 to the haptic fluid chamber 120. The pair of fluid channels 122 can be spaced apart from one 3 another. For example, the pair of fluid channels 122 can be spaced apart between about 0.1 4 mm to about 1.0 mm. In some embodiments, each of the pair of fluid channels 122 has a diameter of between about 0.4 mm to about 0.6 mm.
6 [0077] In some embodiments, the pair of fluid channels 122 can be defined and extend 7 through part of the optic portion 102. More specifically, the pair of fluid channels 122 can be 8 defined and extend through the posterior element 108.
9 [0078] Fig. lA illustrates that one or more haptics 104 of the peripheral portion 103 can be coupled to the optic portion 102 at a haptic-optic interface 124. For example, the one or more 11 haptics 104 can be coupled to the optic portion at a reinforced portion 126 (see Fig. 1D) along 12 the optic portion 102. The reinforced portion 126 can be part of the haptic-optic interface 124.
13 The pair of fluid channels 122 can be defined or formed within part of the reinforced portion 14 126.
[0079] The optic fluid chamber 110 can be in fluid communication with the first haptic fluid 16 chamber 120A through a first pair of fluid channels 122A. The optic fluid chamber 110 can 17 also be in fluid communication with the second haptic fluid chamber 120B
through a second 18 pair of fluid channels 122B.
19 [0080] The two fluid channels of the first pair of fluid channels 122A
can be spaced apart from one another. The two fluid channels of the first pair of fluid channels 122A
can be spaced apart 21 from one another between about 0.1 mm to about 1.0 mm. The two fluid channels of the 22 second pair of fluid channels 122B can be spaced apart from one another.
The two fluid 23 channels of the second pair of fluid channels 12213 can be spaced apart from one another 24 between about 0.1 mm to about 1.0 mm.
[0081] In some embodiments, the first pair of fluid channels 122A and the second pair of fluid 26 channels 122B can be positioned substantially on opposite sides of the optic portion 102. The 27 first pair of fluid channels 122A can be positioned substantially diametrically opposed to the 28 second pair of fluid channels 122B.
29 [0082] The first pair of fluid channels 122A and the second pair of fluid channels 122B can be defined or extend through part of the optic portion 102. The first pair of fluid channels 122A
1 and the second pair of fluid channels 122B can be defined or extend through the posterior 2 element 108.
3 [0083] A design with two fluid channels 122 rather than one channel helps maintain 4 dimensional stability during assembly, which can be important when assembling flexible and thin components. Additionally, it was observed through experimentation that a design with 6 two fluid channels 122 provided better optical quality than certain one-channel designs 7 throughout the range of accommodation. The additional stiffness of the two fluid channel 8 design results in less deflection due to pressure changes in the fluid channels.
9 [0084] As shown in Fig. 1D, the optic portion 102 can comprise a first reinforced portion 126A and a second reinforced portion 126B substantially on opposing sides of the optic 11 portion 102 or substantially diametrically opposed to one another. The first pair of fluid 12 channels 122A can be defined or formed within the first reinforced portion 126A. The second 13 pair of fluid channels 12213 can be defined or formed within the second reinforced portion 14 12613.
[0085] The pair of fluid channels 122 (e.g., any of the first pair of fluid channels 122A or the 16 second pair of fluid channels 12213) can have a pair of inner apertures 128 disposed at one end 17 of the fluid channels 122 and another pair of outer apertures 130 disposed at the other end of 18 the fluid channels 122. The pair of inner apertures 128 can be defined or formed on part of the 19 posterior element 108. As shown in Figs. 1B-1D, the inner apertures 128 can be defined or formed on part of a raised inner surface 132 of the posterior element 108. In some 21 embodiments, the raised inner surface 132 can be a sloped or beveled surface.
22 [0086] The pair of outer apertures 130 can be defined or formed on part of a protruding outer 23 surface 134 of the posterior element 108_ The protruding outer surface 134 can be part of the 24 reinforced portion 126. The protruding outer surface 134 can also be part of the haptic-optic interface 124.
26 [0087] For example, Fig. 1D shows a pair of inner apertures 128 disposed at one end of the 27 first pair of fluid channels 122A and defined along the raised inner surface 132 of the posterior 28 element 108. Fig. ID also shows a pair of outer apertures 130 serving as ends of the second 29 pair of fluid channels 12213 and defined along the protruding outer surface 134 of the posterior element 108. The pair of outer apertures 130 of the first pair of fluid channels 122A and the 31 pair of inner apertures 128 of the second pair of fluid channels 122B
are obscured in Fig. 1D.
1 [0088] The two apertures of the pair of inner apertures 128 can be spaced apart from one 2 another between about 0.1 mm to about 1.0 mm. The two apertures of the pair of outer 3 apertures 130 can be spaced apart from one another between about 0.1 mm to about 1.0 mm.
4 The pair of inner apertures 128 of the first pair of fluid channels 122A
can be positioned diametrically opposed to or on opposite sides of the raised inner surface 132 from the pair of 6 inner apertures 128 of the second pair of fluid channels 122B.
7 [0089] Fig. 1D also illustrates that each of the haptics 104 (e.g., any of the first haptic 104A or 8 the second haptic 10413) can have an optic attachment end 136 and a closed free end 138. A
9 haptic fluid port 140 can be defined at the optic attachment end 136 of the haptic 104. The haptic fluid port 140 can serve as a chamber opening of the haptic fluid chamber 120. Fluid 11 within the haptic fluid chamber 120 can flow out of the haptic fluid chamber 120 through the 12 haptic fluid port 140 and into the optic fluid chamber 110 via the pair of fluid channels 122 13 when the haptic 104 is coupled to the optic portion 102. Similarly, fluid within the optic fluid 14 chamber 110 can flow out of the optic fluid chamber 110 through the pair of fluid channels 122 and into the haptic fluid chamber 120 through the haptic fluid port 140.
16 [0090] As shown in Figs. IA and 1D, a haptic 104- can couple to the optic portion 102 at a 17 reinforced portion 126. For example, the first haptic 104A can couple or be attached to the 18 optic portion 102 at the first reinforced portion 126A and the second haptic 10413 can couple 19 or be attached to the optic portion 102 at the second reinforced portion 12613.
[0091] More specifically, the haptic attachment end 136 can couple to the protruding outer 21 surface 134 of the posterior element 108. The protruding outer surface 134 can also be referred 22 to as a "landing" or "haptic attachment landing." The protruding outer surface 134 can extend 23 out radially from an outer peripheral surface 142 of the optic portion 102. For example, the 24 protruding outer surface 134 can extend out radially from an outer peripheral surface 142 of the posterior element 108 of the optic portion 102. The protruding outer surface 134 can 26 extend out radially from the outer peripheral surface 142 between about
12 [0029] The energy absorbing constituent can comprise between about 0.025% to about 1.0%
13 (or, more specifically, about 0.045% to about 0.45%) by weight of the composite material. In 14 some embodiments, the energy absorbing constituent can be an energy absorbing colorant. For example, a color of the energy absorbing colorant can be visually perceptible to a clinician or 16 another medical professional when the acconunodating intraocular lens is implanted within an 17 eye.
18 [0030] The energy absorbing colorant can be a dye. For example, the dye can be an azo dye. In 19 some embodiments, the dye can be a red azo dye such as Disperse Red 1 dye. The energy absorbing colorant can also comprise a pigment. For example, the pigment can be graphitized 21 carbon black.
22 [0031] In some embodiments, at least one of the optic portion and the peripheral portion can 23 be made in part of a first composite material and a second composite material. The first 24 composite material can comprise a first energy absorbing colorant. The second composite material can comprise a second energy absorbing colorant. In certain embodiments, the color 26 of the first energy absorbing colorant can be different from the color of the second energy 27 absorbing colorant.
28 [0032] In addition to the copolymer blend, the composite base material can further comprise at 29 least one of one or more reactive acrylic monomer diluents, a photoinitiator, and a thermal initiator. The copolymer blend can comprise an alkyl acrylate, a fluoro-alkyl acrylate, and a 31 phenyl-alkyl acrylate. The composite material can remain relatively fixed at one or more 1 locations within the optic portion or the peripheral portion during all phases of accommodation 2 or disaccornmodation of the intraocular lens.
3 [0033] As previously discussed, the base power of the adjustable accommodating intraocular 4 lens can be configured to change in response to an external energy directed at a composite material making up at least part of the adjustable acconunodating intraocular lens. The base 6 power of the optic portion can be configured to change between about 0.05 D to about -0.5 D
7 (e.g., more specifically, between about 0.1 D to about 0.2 D) in response to pulses of the 8 external energy directed at the composite material. In some embodiments, the base power of 9 the optic portion can be configured to change by up to 2.0 D in total.
In other embodiments, the base power of the optic portion can be configured to change by up to -15.0 D in total.
11 [0034] In some embodiments, the external energy can be light energy. The external energy can 12 be light energy from a laser light. The light energy can have a wavelength between about 488 13 nm to about 650 nm. For example, the light energy can be green laser light having a 14 wavelength between about 520 nm to about 570 nm. As a more specific example, the light energy can be green laser light having a wavelength of about 532 nm.
16 [0035] The external energy directed or otherwise applied to the composite material can cause a 17 persistent change in an optical parameter of the adjustable accommodating intraocular lens.
18 For example, the external energy directed or otherwise applied to the composite material can 19 cause a persistent change in the base power of the adjustable accommodating intraocular lens.
Also, for example, the external energy directed or otherwise applied to the composite material 21 can cause a persistent change in the cylindricity of the optic portion of the adjustable 22 accommodating intraocular lens.
23 [0036] In some embodiments, the optic portion can be made in part of the composite material.
24 In these embodiments, at least one of the base power and the cylindricity of the optic portion can be configured to change in response to the external energy directed at the optic portion.
26 For example, the composite material can be located along a first peripheral edge of an anterior 27 element of the optic portion. In this example, the composite material can also be located along 28 a second peripheral edge diametrically opposed to the first peripheral edge. The cylindricity of 29 the anterior optical surface can be configured to change in response to the external energy directed at the first peripheral edge and the second peripheral edge.
1 [0037] Alternatively, the composite material can also be located along a first peripheral edge 2 along a second peripheral edge of a posterior element of the optic portion. The second 3 peripheral edge can be diametrically opposed to the first peripheral edge. The cylindricity of 4 the posterior optical surface can be configured to change in response to the external energy directed at the first peripheral edge and the second peripheral edge.
6 [0038] As previously discussed, the anterior element of the optic portion can be bonded or 7 otherwise adhered circumferentially to the posterior element by an adhesive layer. In some 8 embodiments, the adhesive layer can comprise the composite material. The base power of the 9 optic portion can be configured to decrease in response to an external energy directed at the adhesive layer. The adhesive layer can be configured to expand in response to the external 11 energy directed at the adhesive layer. Expansion of the adhesive layer can cause a volume of 12 the optic fluid chamber within the optic portion to increase. An increase in the volume of the 13 optic fluid chamber can cause an internal fluid pressure within the optic fluid chamber to 14 decrease, thereby causing the anterior element to flatten or decrease its curvature.
[0039] In other embodiments, the peripheral portion (e.g., the haptic(s)) of the adjustable 16 accommodating intraocular lens can be made in part of the composite material_ As previously 17 discussed, the peripheral portion can include at least one haptic comprising a fluid-filled haptic 18 fluid chamber in fluid communication with the optic chamber. The base power of the optic 19 portion can be configured to change in response to the external energy directed at portions of the peripheral portion made in part of the composite material. The external energy can cause 21 fluid flow or fluid displacement between the fluid-filled optic chamber and the haptic fluid 22 chamber.
23 [0040] For example, the base power can be configured to change in response to a change in 24 the volume of the haptic fluid chamber. Also, for example, the base power of the adjustable accommodating intraocular lens can be configured to change in response to an interaction 26 between the peripheral portion and a capsular environment surrounding the adjustable 27 accommodating intraocular lens when the lens is implanted within an eye.
28 [0041] More specifically, the composite material can be configured or designed as a spacer 29 extending radially from a haptic chamber wall. The spacer can be configured to expand in response to the external energy directed at the spacer. Expansion of the spacer can result in a 1 reduction of the volume of the haptic fluid chamber by pushing the haptic(s) against one or 2 more capsular bag walls.
3 [0042] The composite material can also be located partly within a haptic chamber wall 4 surrounding the haptic fluid chamber. For example, the composite material can be located at least partially within a channel formed along a radially inner wall of the haptic. A volume of 6 the haptic fluid chamber can be configured to increase in response to the external energy 7 directed at the composite material.
8 [0043] In other embodiments, the composite material can be positioned or located at least 9 partially along a radially outermost portion of a radially inner wall of the haptic. A volume of the haptic fluid chamber can be configured to decrease in response to the external energy 11 directed at the composite material. In at least some of these embodiments, the composite 12 material can expand into the haptic fluid chamber in response to the external energy directed at 13 the composite material.
14 [0044] In further embodiments, a haptic of the adjustable accommodating intraocular lens can comprise a first haptic portion and a second haptic portion. The first haptic portion and the 16 second haptic portion can be made in part of the composite material. A
base power of the optic 17 portion can be configured to increase in response to an external energy directed at the first 18 haptic portion. For example, the base power of the optic portion can be configured to increase 19 in response to fluid flowing from the haptic fluid chamber to the optic fluid chamber as a result of the external energy directed at the first haptic portion.
21 [0045] Moreover, the base power of the optic portion can be configured to decrease in 22 response to the external energy directed at the second haptic portion.
The base power of the 23 optic portion can be configured to decrease in response to fluid flowing from the optic fluid 24 chamber to the haptic fluid chamber as a result of the external energy directed at the second haptic portion. At least one of the first haptic portion and the second haptic portion can be 26 located partly within a haptic chamber wall surrounding the haptic fluid chamber.
27 [0046] hi some embodiments, the first haptic portion can be made in part of a first composite 28 material and the second haptic portion can be made in part of a second composite material.
29 The first composite material can comprise a first energy absorbing constituent and the second composite material can comprise a second energy absorbing constituent. The composition of 31 the first energy absorbing constituent can be different from the composition of the second 1 energy absorbing constituent. For example, the first energy absorbing constituent can be an 2 energy absorbing dye having a first color. In this example, the second energy absorbing 3 constituent can be another energy absorbing dye having a second color different from the first 4 color.
[0047] The first haptic portion can be radially offset from the second haptic portion. In some 6 embodiments, at least one of the first haptic portion and the second haptic portion can be 7 oriented in a pattern such that a location of the at least one of the first haptic portion and the 8 second haptic portion along the haptic is visually perceptible to a clinician or another medical 9 professional.
[0048] A method of adjusting an accommodating intraocular lens is also disclosed. The 11 method can comprise adjusting a base power of the acconunodating intraocular lens by 12 directing an external energy at a composite material within at least one of an optic portion and 13 a peripheral portion of the accommodating intraocular lens. The composite material can 14 comprise an energy absorbing constituent, a plurality of expandable components, and the composite base material made in part of the copolymer blend.
16 [0049] The method can further comprise adjusting the base power of the accommodating 17 intraocular lens when the accommodating intraocular lens is implanted within an eye of a 18 subject. The method can further comprise adjusting the cylindricity of an optical surface of the 19 optic portion of the accommodating intraocular lens by directing an external energy at the composite material arranged at diametrically opposed peripheral edges of the optic portion.
21 [0050] The method can also comprise directing the external energy at the composite material 22 to energize the energy absorbing constituent to cause thermal energy to be transferred to the 23 expandable components. In some embodiments, the plurality of expandable components can 24 be expandable microspheres comprising a blowing agent contained within thermoplastic shells. Directing the external energy at the composite material can cause the rnicrospheres to 26 expand.
27 [0051] In some embodiments, the external energy can be light energy. For example, the light 28 energy can be laser light having a wavelength between about 488 nm to about 650 nm.
29 [0052] The method can further comprise adjusting the base power of the optic portion between about 0.05 D to about 0.5 D (e.g., more specifically, between about 0.1 D
to about 0.2 D) 31 in response to pulses of the external energy directed at the composite material.
1 [0053] The method can also comprise directing the external energy at the composite material 2 to displace fluid between the optic chamber and the haptic fluid chamber.
For example, the 3 method can comprise directing the external energy at the composite material to change a 4 volume of the haptic fluid chamber. This change in the volume of the haptic fluid chamber can result in a change in the base power of the accommodating intraocular lens.
The method can 6 further comprise adjusting the base power of the accommodating intraocular lens by directing 7 the external energy at the composite material to cause a haptic of the lens to interact with a 8 capsular environment surrounding the implanted accommodating intraocular lens.
9 [0054] Moreover, the method can also comprise adjusting the base power of the accommodating intraocular lens by directing the external energy at the composite material to 11 change a volume of the optic fluid chamber. This change in the volume of the optic fluid 12 chamber can result in fluid flow out of the optical fluid chamber, thereby causing part of the 13 optic portion to change shape and the base power of the lens to decrease.
BRIEF DESCRIPTION OF THE DRAWINGS
16 [0055] Fig. lA illustrates a top plan view of an embodiment of an adjustable accommodating 17 intraocular lens.
18 [0056] Figs. 1B and 1C illustrate sectional views of an embodiment of the adjustable 19 accommodating intraocular lens.
[0057] Fig. 1D illustrates an exploded view of an embodiment of the adjustable 21 accommodating intraocular lens.
22 [0058] Fig. 2A illustrates a composite material used to make at least part of the adjustable 23 accommodating intraocular lens.
24 [0059] Fig. 2B illustrates one embodiment of an expandable component of the composite material.
26 [0060] Figs. 3A and 3B illustrate sectional views of an embodiment of the adjustable 27 accommodating intraocular lens comprising an expandable spacer.
28 [0061] Figs. 4A and 4B illustrate top and sectional views, respectively, of another embodiment 29 of the adjustable accommodating intraocular lens comprising the expandable spacer extending radially inward.
1 [0062] Figs. 5A and 5B illustrate sectional views of another embodiment of the adjustable 2 accommodating intraocular lens comprising an expandable spreader.
3 [0063] Fig. 6 illustrates a sectional view of another embodiment of the adjustable 4 accommodating intraocular lens comprising an expandable protuberance.
[0064] Figs. 7A and 7B illustrate top and sectional views, respectively, of another embodiment 6 of the adjustable acconunodating intraocular lens comprising both an expandable spreader and 7 an expandable protuberance.
8 [0065] Fig. 8 illustrates a top plan view of another embodiment of the adjustable 9 accommodating intraocular lens comprising both expandable spreaders and expandable protuberances implemented as discrete components along the haptics.
11 [0066] Fig. 9A illustrates a top plan view of another embodiment of the adjustable 12 accommodating intraocular lens comprising both expandable spreaders and expandable 13 protuberances arranged in a visually perceptible pattern.
14 [0067] Fig. 9B illustrates a sectional view of the embodiment of the adjustable accommodating intraocular lens shown in Fig. 9A taken along cross-section A-A.
16 [0068] Fig. 9C illustrates a sectional view of the embodiment of the adjustable 17 accommodating intraocular lens shown in Fig. 9A taken along cross-section B-B.
18 [0069] Fig. 10 illustrates a sectional view of an optic portion of another embodiment of the 19 adjustable accommodating intraocular lens comprising an adhesive layer made in part of the composite material.
21 [0070] Fig. 11 illustrates a perspective view of another embodiment of the adjustable 22 accommodating intraocular lens configured to exhibit cylindricity in response to an external 23 energy directed at the adjustable accommodating intraocular lens.
DETAILED DESCRIPTION
26 [0071] Fig. lA illustrates a top plan view of an embodiment of an adjustable accommodating 27 intraocular lens (AIOL) 100 for correcting defocus aberration, corneal astigmatism, spherical 28 aberration, or a combination thereof. The adjustable AIOL 100 can comprise an optic portion 29 102 and a peripheral portion 103 that, in this embodiment, comprises one or more haptics 104 including a first haptic 104A and a second haptic 104B coupled to and extending peripherally 1 from the optic portion 102. The adjustable AIOL 100 is configured to be positioned within a 2 native capsular bag in which a native lens has been removed.
3 [0072] When implanted within the native capsular bag, the optic portion 102 can be adapted to 4 refract light that enters the eye onto the retina. The peripheral portion 103 (e.g., the one or more haptics 104) can be configured to engage the capsular bag and is adapted to deform in 6 response to ciliary muscle movement (e.g., muscle relaxation, muscle contraction, or a 7 combination thereof) in connection with capsular bag reshaping.
Engagement of the peripheral 8 portion 103 (e.g., the one or more haptics 104) with the capsular bag will be discussed in more 9 detail in the following sections.
[0073] Figs. 1B and 1C illustrate sectional views of an embodiment of the adjustable AIOL
11 100 as taken along cross-section A-A of Fig. 1A. As shown in Figs. 1B
and 1C, the optic 12 portion 102 can comprise an anterior element 106 and a posterior element 108. A fluid-filled 13 optic fluid chamber 110 can be defined in between the anterior element 106 and the posterior 14 element 108.
[0074] The anterior element 106 can comprise an anterior optical surface 112 and an anterior 16 inner surface 114 opposite the anterior optical surface 112_ The posterior element 108 can 17 comprise a posterior optical surface 116 and a posterior inner surface 118 opposite the 18 posterior optical surface 116. Any of the anterior optical surface 112, the posterior optical 19 surface 116, or a combination thereof can be considered and referred to as an external optical surface. The anterior inner surface 114 and the posterior inner surface 118 can face the optic 21 fluid chamber 110. At least part of the anterior inner surface 114 and at least part of the 22 posterior inner surface 118 can serve as chamber walls of the optic fluid chamber 110.
23 [0075] Each of the one or more haptics 104 can comprise a haptic fluid chamber 120 within 24 the haptic 104. For example, the first haptic 104A can comprise a first haptic fluid chamber 120A within the first haptic 104A and the second haptic 104B can comprise a second haptic 26 fluid chamber 120B within the second haptic 104B. The haptic fluid chamber 120 (e.g., any of 27 the first haptic fluid chamber 120A, the second haptic fluid chamber 120B, or a combination 28 thereof) can be in fluid communication with or fluidly connected to the optic fluid chamber 29 110.
[0076] The optic fluid chamber 110 can be in fluid communication with the one or more 31 haptic fluid chambers 120 through a pair of fluid channels 122 (see Fig.
1A). The fluid 1 channels 122 can be conduits or passageways fluidly connecting the optic fluid chamber 110 2 to the haptic fluid chamber 120. The pair of fluid channels 122 can be spaced apart from one 3 another. For example, the pair of fluid channels 122 can be spaced apart between about 0.1 4 mm to about 1.0 mm. In some embodiments, each of the pair of fluid channels 122 has a diameter of between about 0.4 mm to about 0.6 mm.
6 [0077] In some embodiments, the pair of fluid channels 122 can be defined and extend 7 through part of the optic portion 102. More specifically, the pair of fluid channels 122 can be 8 defined and extend through the posterior element 108.
9 [0078] Fig. lA illustrates that one or more haptics 104 of the peripheral portion 103 can be coupled to the optic portion 102 at a haptic-optic interface 124. For example, the one or more 11 haptics 104 can be coupled to the optic portion at a reinforced portion 126 (see Fig. 1D) along 12 the optic portion 102. The reinforced portion 126 can be part of the haptic-optic interface 124.
13 The pair of fluid channels 122 can be defined or formed within part of the reinforced portion 14 126.
[0079] The optic fluid chamber 110 can be in fluid communication with the first haptic fluid 16 chamber 120A through a first pair of fluid channels 122A. The optic fluid chamber 110 can 17 also be in fluid communication with the second haptic fluid chamber 120B
through a second 18 pair of fluid channels 122B.
19 [0080] The two fluid channels of the first pair of fluid channels 122A
can be spaced apart from one another. The two fluid channels of the first pair of fluid channels 122A
can be spaced apart 21 from one another between about 0.1 mm to about 1.0 mm. The two fluid channels of the 22 second pair of fluid channels 122B can be spaced apart from one another.
The two fluid 23 channels of the second pair of fluid channels 12213 can be spaced apart from one another 24 between about 0.1 mm to about 1.0 mm.
[0081] In some embodiments, the first pair of fluid channels 122A and the second pair of fluid 26 channels 122B can be positioned substantially on opposite sides of the optic portion 102. The 27 first pair of fluid channels 122A can be positioned substantially diametrically opposed to the 28 second pair of fluid channels 122B.
29 [0082] The first pair of fluid channels 122A and the second pair of fluid channels 122B can be defined or extend through part of the optic portion 102. The first pair of fluid channels 122A
1 and the second pair of fluid channels 122B can be defined or extend through the posterior 2 element 108.
3 [0083] A design with two fluid channels 122 rather than one channel helps maintain 4 dimensional stability during assembly, which can be important when assembling flexible and thin components. Additionally, it was observed through experimentation that a design with 6 two fluid channels 122 provided better optical quality than certain one-channel designs 7 throughout the range of accommodation. The additional stiffness of the two fluid channel 8 design results in less deflection due to pressure changes in the fluid channels.
9 [0084] As shown in Fig. 1D, the optic portion 102 can comprise a first reinforced portion 126A and a second reinforced portion 126B substantially on opposing sides of the optic 11 portion 102 or substantially diametrically opposed to one another. The first pair of fluid 12 channels 122A can be defined or formed within the first reinforced portion 126A. The second 13 pair of fluid channels 12213 can be defined or formed within the second reinforced portion 14 12613.
[0085] The pair of fluid channels 122 (e.g., any of the first pair of fluid channels 122A or the 16 second pair of fluid channels 12213) can have a pair of inner apertures 128 disposed at one end 17 of the fluid channels 122 and another pair of outer apertures 130 disposed at the other end of 18 the fluid channels 122. The pair of inner apertures 128 can be defined or formed on part of the 19 posterior element 108. As shown in Figs. 1B-1D, the inner apertures 128 can be defined or formed on part of a raised inner surface 132 of the posterior element 108. In some 21 embodiments, the raised inner surface 132 can be a sloped or beveled surface.
22 [0086] The pair of outer apertures 130 can be defined or formed on part of a protruding outer 23 surface 134 of the posterior element 108_ The protruding outer surface 134 can be part of the 24 reinforced portion 126. The protruding outer surface 134 can also be part of the haptic-optic interface 124.
26 [0087] For example, Fig. 1D shows a pair of inner apertures 128 disposed at one end of the 27 first pair of fluid channels 122A and defined along the raised inner surface 132 of the posterior 28 element 108. Fig. ID also shows a pair of outer apertures 130 serving as ends of the second 29 pair of fluid channels 12213 and defined along the protruding outer surface 134 of the posterior element 108. The pair of outer apertures 130 of the first pair of fluid channels 122A and the 31 pair of inner apertures 128 of the second pair of fluid channels 122B
are obscured in Fig. 1D.
1 [0088] The two apertures of the pair of inner apertures 128 can be spaced apart from one 2 another between about 0.1 mm to about 1.0 mm. The two apertures of the pair of outer 3 apertures 130 can be spaced apart from one another between about 0.1 mm to about 1.0 mm.
4 The pair of inner apertures 128 of the first pair of fluid channels 122A
can be positioned diametrically opposed to or on opposite sides of the raised inner surface 132 from the pair of 6 inner apertures 128 of the second pair of fluid channels 122B.
7 [0089] Fig. 1D also illustrates that each of the haptics 104 (e.g., any of the first haptic 104A or 8 the second haptic 10413) can have an optic attachment end 136 and a closed free end 138. A
9 haptic fluid port 140 can be defined at the optic attachment end 136 of the haptic 104. The haptic fluid port 140 can serve as a chamber opening of the haptic fluid chamber 120. Fluid 11 within the haptic fluid chamber 120 can flow out of the haptic fluid chamber 120 through the 12 haptic fluid port 140 and into the optic fluid chamber 110 via the pair of fluid channels 122 13 when the haptic 104 is coupled to the optic portion 102. Similarly, fluid within the optic fluid 14 chamber 110 can flow out of the optic fluid chamber 110 through the pair of fluid channels 122 and into the haptic fluid chamber 120 through the haptic fluid port 140.
16 [0090] As shown in Figs. IA and 1D, a haptic 104- can couple to the optic portion 102 at a 17 reinforced portion 126. For example, the first haptic 104A can couple or be attached to the 18 optic portion 102 at the first reinforced portion 126A and the second haptic 10413 can couple 19 or be attached to the optic portion 102 at the second reinforced portion 12613.
[0091] More specifically, the haptic attachment end 136 can couple to the protruding outer 21 surface 134 of the posterior element 108. The protruding outer surface 134 can also be referred 22 to as a "landing" or "haptic attachment landing." The protruding outer surface 134 can extend 23 out radially from an outer peripheral surface 142 of the optic portion 102. For example, the 24 protruding outer surface 134 can extend out radially from an outer peripheral surface 142 of the posterior element 108 of the optic portion 102. The protruding outer surface 134 can 26 extend out radially from the outer peripheral surface 142 between about
10 microns and 1.0 27 mm or between about 10 microns and 500 microns.
28 [0092] The haptic attachment end 136 can have a substantially flat surface to adhere or 29 otherwise couple to a substantially flat surface of the protruding outer surface 134. When the haptic attachment end 136 is coupled to the protruding outer surface 134, the haptic fluid port 31 140 can surround the outer apertures 130 of the fluid channels 122. The haptics 104 can be 1 coupled or adhered to the optic portion 102 via biocompatible adhesives 148. In some 2 embodiments, the adhesives 148 can be the same adhesives used to couple or adhere the 3 anterior element 106 to the posterior element 108. The adhesives 148 will be discussed in 4 more detail in the following sections.
[0093] Each of the haptics 104 can also comprise a radially outer portion 144 configured to 6 face and contact an inner surface of a patient's capsular bag when the adjustable AIOL 100 is 7 implanted within the capsular bag. Each of the haptics 104 can also comprise a radially inner 8 portion 146 configured to face the outer peripheral surface 142 of the optic portion 102.
9 Engagement of the capsular bag with the radially outer portion 144 of the haptics 104 will be discussed in more detail in the following sections.
28 [0092] The haptic attachment end 136 can have a substantially flat surface to adhere or 29 otherwise couple to a substantially flat surface of the protruding outer surface 134. When the haptic attachment end 136 is coupled to the protruding outer surface 134, the haptic fluid port 31 140 can surround the outer apertures 130 of the fluid channels 122. The haptics 104 can be 1 coupled or adhered to the optic portion 102 via biocompatible adhesives 148. In some 2 embodiments, the adhesives 148 can be the same adhesives used to couple or adhere the 3 anterior element 106 to the posterior element 108. The adhesives 148 will be discussed in 4 more detail in the following sections.
[0093] Each of the haptics 104 can also comprise a radially outer portion 144 configured to 6 face and contact an inner surface of a patient's capsular bag when the adjustable AIOL 100 is 7 implanted within the capsular bag. Each of the haptics 104 can also comprise a radially inner 8 portion 146 configured to face the outer peripheral surface 142 of the optic portion 102.
9 Engagement of the capsular bag with the radially outer portion 144 of the haptics 104 will be discussed in more detail in the following sections.
11 [0094] The optic portion 102 can have a base power or base spherical power. The base power
12 of the optic portion 102 can be configured to change based on an internal fluid pressure within
13 the fluid-filled optic fluid chamber 110. The base power of the optic portion 102 can be
14 configured to increase or decrease as fluid enters or exits the fluid-filled optic fluid chamber 110.
16 [0095] The base power of the optic portion 102 can be configured to increase as fluid enters 17 the fluid-filled optic fluid chamber 110 from the haptic fluid chamber(s) 120, as shown in Fig.
18 1B. The base power of the optic portion 102 can be configured to decrease as fluid exits or is 19 drawn out of the fluid-filled optic fluid chamber 110 into the haptic fluid chamber(s) 120, as shown in Fig. 1C.
21 [0096] It should be noted that although Fig. 1B illustrates the fluid entering the optic fluid 22 chamber 110 from the haptic fluid chambers 120 using the curved broken-line arrows, fluid 23 enters the optic fluid chamber 110 via the fluid channels 122 (including through the inner 24 apertures 128 and outer apertures 130) and haptic fluid ports 140. It should also be noted that although Fig. 1C illustrates the fluid exiting the optic fluid chamber 110 into the haptic fluid 26 chambers 120 using the curved broken-line arrows, fluid exits the optic fluid chamber 110 via 27 the fluid channels 122 (including through the inner apertures 128 and outer apertures 130) and 28 haptic fluid ports 140.
29 [0097] The optic portion 102 can be made in part of a deformable or flexible material. In some embodiments, the optic portion 102 can be made in part of a deformable or flexible polymeric 31 material. For example, the anterior element 106, the posterior element 108, or a combination 1 thereof can be made in part of a deformable or flexible polymeric material. The one or more 2 haptics 104 (e.g., the first haptic 104A, the second haptic 104B, or a combination thereof) can 3 be made in part of the same deformable or flexible material as the optic portion 102. In other 4 embodiments, the one or more haptics 104 can be made in part of different materials from the optic portion 102.
6 [0098] In some embodiments, the optic portion 102 can comprise or be made in part of a lens 7 body material. The lens body material can be made in part of a cross-linked copolymer 8 comprising a copolymer blend. The copolymer blend can comprise an alkyl acrylate or 9 methacrylate, a fluoro-alkyl (meth)acrylate, and a phenyl-alkyl acrylate.
It is contemplated by this disclosure and it should be understood by one of ordinary skill in the art that these types of 11 acrylic cross-linked copolymers can be generally copolymers of a plurality of acrylates, 12 methacrylates, or a combination thereof and the term "acrylate" as used herein can be 13 understood to mean acrylates, methacrylates, or a combination thereof interchangeably unless 14 otherwise specified. The cross-linked copolymer used to make the lens body material can comprise an alkyl acrylate in the amount of about 3% to 20% (wt%), a fluoro-alkyl acrylate in 16 the amount of about 10% to 35% (wt%), and a phenyl-alkyl acrylate in the amount of about 17 50% to 80% (wt%). In some embodiments, the cross-linked copolymer can comprise or be 18 made in part of an n-butyl acrylate as the alkyl acrylate, trifluoroethyl methacrylate as the 19 fluoro-alkyl acrylate, and phenylethyl acrylate as the phenyl-alkyl acrylate. More specifically, the cross-linked copolymer used to make the lens body material can comprise n-butyl acrylate 21 in the amount of about 3% to 20% (wt%) (e.g., between about 12% to 16%), trifluoroethyl 22 methacrylate in the amount of about 10% to 35% (wt%) (e.g., between about 17% to 21%), 23 and phenylethyl acrylate in the amount of about 50% to 80% (wt%) (e.g., between about 64%
24 to 67%).
[0099] The final composition of the cross-linked copolymer used to make the lens body 26 material can also comprise a cross-linker or cross-linking agent such as ethylene glycol 27 dimethacrylate (EGDMA). For example, the final composition of the cross-linked copolymer 28 used to make the lens body material can also comprise a cross-linker or cross-linking agent 29 (e.g., EGDMA) in the amount of about 1.0%. The final composition of the cross-linked copolymer used to make the lens body material can also comprise an initiator or initiating 31 agent (e.g., Perkadox 16) and a UV absorber.
1 [0100] The haptic(s) 104 can comprise or be made in part of a haptic material. The haptic 2 material can comprise or be made in part of a cross-linked copolymer comprising a copolymer 3 blend. The copolymer blend can comprise an alkyl acrylate, a fluoro-alkyl acrylate, and a 4 phenyl-alkyl acrylate. For example, the cross-linked copolymer used to make the haptic material can comprise an alkyl acrylate in the amount of about 10% to 25%
(wt%), a fluoro-6 alkyl acrylate in the amount of about 10% to 35% (wt%), and a phenyl-alkyl acrylate in the 7 amount of about 50% to 80% (wt%). In some embodiments, the cross-linked copolymer used 8 to make the haptic material can comprise n-butyl acrylate in the amount of about 10% to 25%
9 (wt%) (e.g., between about 19% to about 23%), trifluoroethyl methacrylate in the amount of about 10% to 35% (wt%) (e.g., between about 14% to about 18%), and phenylethyl acrylate in 11 the amount of about 50% to 80% (wt%) (e.g., between about 58% to about 62%). The final 12 composition of the cross-linked copolymer used to make the haptic material can also comprise 13 a cross-linker or cross-linking agent, such as EGDMA, in the amount of about 1.0%. The final 14 composition of the cross-linked copolymer used to make the haptic material can also comprise a number of photoinitiators or photoinitiating agents (e.g., camphorquinone, 1-phenyl-1,2-16 propanedione, and 2-ethylhexy1-4-(dimenthylamino)benzoate).
17 [0101] In some embodiments, the refractive index of the lens body material can be between 18 about 1.48 and about 1.53. In certain embodiments, the refractive index of the lens body 19 material can be between about 1.50 and about 1.53 (e.g., about 1.5178).
[0102] The optic portion 102 can be configured to deform, flex, or otherwise change shape 21 (see Figs. 1B and 1C) in response to fluid entering or exiting the optic fluid chamber 110. The 22 optic portion 102 can be configured to deform, flex, or otherwise change shape as a result of 23 the material composition (e.g., the polymeric composition) of the optic portion 102 discussed 24 heretofore. The haptic(s) 104 can also be configured to deform or otherwise change shape in response to interactions or engagement with the capsular bag of a patient when the adjustable 26 AIOL 100 is implanted within an eye of the patient. The haptic(s) 104 can be configured to 27 deform or otherwise change shape as a result of the material composition of the haptics 104.
28 [0103] In some embodiments, the anterior element 106 can be configured to deform, flex, or 29 otherwise change shape (e.g., change its curvature) in response to fluid entering or exiting the optic fluid chamber 110. In other embodiments, the posterior element 108 can be configured to 31 deform, flex, or otherwise change shape (e.g., change its curvature) in response to fluid 1 entering or exiting the optic fluid chamber 110. In further embodiments, both the anterior 2 element 106 and the posterior element 108 can be configured to deform, flex, or otherwise 3 change their shapes in response to fluid entering or exiting the optic fluid chamber 110.
4 [0104] In some embodiments, the fluid within the optic fluid chamber 110, the haptic fluid chamber(s) 120, or a combination thereof can be an oil. More specifically, in certain 6 embodiments, the fluid within the optic fluid chamber 110, the haptic fluid chamber(s) 120, or 7 a combination thereof can be a silicone oil or fluid. The fluid can flow between the optic fluid 8 chamber 110 and the haptic fluid chamber(s) 120 in response to a deformation, flexing, or 9 shape change undertaken by the haptic(s) 104, component(s) of the optic portion 102 (e.g., the anterior element 106, the posterior element 108, or a combination thereof), or a combination 11 thereof.
12 [0105] The fluid within the optic fluid chamber 110, the haptic fluid chamber(s) 120, or a 13 combination thereof can be a silicone oil or fluid comprising or made in part of a diphenyl 14 siloxane. In other embodiments, the silicone oil or fluid can comprise or be made in part of a ratio of two dimethyl siloxane units to one diphenyl siloxane unit. More specifically, in some 16 embodiments, the silicone oil or fluid can be a diphenyltetramethyl cyclotrisiloxane. In 17 additional embodiments, the silicone oil or fluid can comprise or be made in part of a diphenyl 18 siloxane and dimethyl siloxane copolymer.
19 [0106] The fluid (e.g., the silicone oil) can be index matched with the lens body material used to make the optic portion 102. When the fluid is index matched with the lens body material, 21 the entire optic portion 102 containing the fluid acts as a single lens.
For example, the fluid can 22 be selected so that it has a refractive index of between about 1.48 and 1.53 (or between about 23 1.50 and 1.53). In some embodiments, the fluid (e.g., the silicone oil) can have a 24 polydispersity index of between about 1.2 and 1.3. In other embodiments, the fluid (e.g., the silicone oil) can have a polydispersity index of between about 1.3 and 1.5. In other 26 embodiments, the fluid (e.g., the silicone oil) can have a polydispersity index of between about 27 1.1 and 1.2. Other example fluids are described in U.S. Patent Publication No. 2018/0153682, 28 which is herein incorporated by reference in its entirety.
29 [0107] The base power of the optic portion 102 can be configured to change in response to the shape change undertaken by the shape-changing components of the optic portion 102 (e.g., the 31 anterior element 106, the posterior element 108, or a combination thereof). The optic portion 1 102 can be configured to change shape in response to a physiologic muscle movement (e.g., 2 ciliary muscle movement) undertaken by a patient when the adjustable AIOL
100 is implanted 3 within a capsular bag of the eye of the patient and the adjustable AIOL
100 deforms or 4 changes shape in response to ciliary muscle related capsular bag reshaping.
[0108] The adjustable AIOL 100 can be implanted or introduced into a patient's capsular bag 6 after a native lens has been removed from the capsular bag. The patient's capsular bag is 7 connected to zonule fibers which are connected to the patient's ciliary muscles. The capsular 8 bag is elastic and ciliary muscle movements can reshape the capsular bag via the zonule fibers.
9 For example, when the ciliary muscles relax, the zonules are stretched.
This stretching pulls the capsular bag in the generally radially outward direction due to radially outward forces.
11 This pulling of the capsular bag causes the capsular bag to elongate, creating room within the 12 capsular bag. When the patient's native lens is present in the capsular bag, the native lens 13 normally becomes flatter (in the anterior-to-posterior direction), which reduces the power of 14 the lens, allowing for distance vision. In this configuration, the patient's native lens is said to be in a disacconunodated state or undergoing disaccommodation.
16 [0109] When the ciliary muscles contract, however, as occurs when the eye is attempting to 17 focus on near objects, the radially inner portion of the muscles move radially inward, causing 18 the zonules to slacken. The slack in the zonules allows the elastic capsular bag to contract and 19 exert radially inward forces on a lens within the capsular bag. When the patient's native lens is present in the capsular bag, the native lens normally becomes more curved (e.g., the anterior 21 part of the lens becomes more curved), which gives the lens more power, allowing the eye to 22 focus on near objects. In this configuration, the patient's native lens is said to be in an 23 accommodated state or undergoing accommodation_ 24 [0110] Therefore, any AIOLs implanted within the capsular bag should also possess mechanisms which allow for the base power of the AIOL to increase when the ciliary muscles 26 contract and allow for the base power of the AIOL to decrease when the ciliary muscles relax.
27 [0111] In the present case, when the adjustable AIOL 100 is implanted or otherwise 28 introduced into a patient's native capsular bag, the radially outer portions 144 of the haptics 29 104 of the adjustable AIOL 100 can directly engage with or be in physical contact with the portion of the capsular bag that is connected to the zonules or zonule fibers.
Therefore, the 31 radially outer portions 144 of the haptics 104 can be configured to respond to capsular bag 1 reshaping forces that are applied radially when the zonules relax and stretch as a result of 2 ciliary muscle movements.
3 [0112] When the ciliary muscles contract, the peripheral region of the elastic capsular bag 4 reshapes and applies radially inward forces on the radially outer portions 144 of the haptics 104 (for example, the elastic capsular bag applies radially inward forces on the radially outer 6 portion 144 of the first haptic 104A and on the radially outer portion 144 of the second haptic 7 10413). The radially outer portions 144 of the haptics 104 then deform or otherwise changes 8 shape and this deformation or shape change causes the volume of the haptic fluid chambers 9 120 to decrease. When the volume of the haptic fluid chambers 120 decreases, the fluid within the haptic fluid chambers 120 is moved or pushed into the optic fluid chamber 110 within the 11 optic portion 102. As discussed previously, fluid moves from the haptic fluid chamber 120 into 12 the optic fluid chamber 110 through fluid channels 122 (e.g., a pair of fluid channels 122) 13 formed within the optic portion 102.
14 [0113] The optic portion 102 (any of the anterior element 106, the posterior element 108, or a combination thereof) can change shape (increase its curvature) in response to the fluid entering 16 the optic fluid chamber 110 from the haptic fluid chambers 120. This increases the base power 17 or base spherical power of the adjustable AIOL 100 and allows a patient with the adjustable 18 AIOL 100 implanted within the eye of the patient to focus on near objects. The adjustable 19 AIOL 100 can also be considered to be in an accommodated state or have undergone accommodation.
21 [0114] When the ciliary muscles relax, the peripheral region of the elastic capsular bag is 22 stretched radially outward and the capsular bag elongates and more room is created within the 23 capsular bag. The radially outer portions 144 of the haptics 104 can be configured to respond 24 to this capsular bag reshaping by returning to its non-deformed or non-stressed configuration.
This causes the volume of the haptic fluid chambers 120 to increase or return to its non-26 deformed volume. This increase in the volume of the haptic fluid chambers 120 causes the 27 fluid within the optic fluid chamber 110 to be drawn out or otherwise flow out of the optic 28 fluid chamber 110 and back into the haptic fluid chambers 120. As discussed previously, fluid 29 moves out of the optic fluid chamber 110 into the haptic fluid chamber 120 through the same fluid channels 122 (e.g., a pair of fluid channels 122) formed within the optic portion 102.
1 [0115] As previously discussed, the optic portion 102 (any of the anterior element 106, the 2 posterior element 108, or a combination thereof) can change shape (decrease its curvature or 3 become flatter) in response to the fluid exiting the optic fluid chamber 110 and into the haptic 4 fluid chambers 120. This decreases the base power or base spherical power of the adjustable AIOL 100 and allows a patient with the adjustable AIOL 100 implanted within the eye of the 6 patient to focus on distant objects or provide for distance vision. The adjustable AIOL 100 can 7 also be considered to be in a disaccommodated state or have undergone disaccommodation.
8 [0116] As shown in Figs. 1B and IC, the radially inner portion 146 of the haptics 104 can be 9 designed to be thicker or bulkier (relative to the radially outer portion 144) to provide the haptics 104 with stiffness or resiliency in the anterior-to-posterior direction. This way, when 11 capsular bag forces are applied to the haptics 104 in the anterior-to-posterior direction, less 12 deformation occurs and less fluid movement occurs between the haptic fluid chambers 120 and 13 the optic fluid chamber 110 than when forces are applied in the radial direction. Since less 14 fluid movement occurs, less changes in the base power of the adjustable AIOL 100 occur when forces are applied to the adjustable AIOL 100 in the anterior-to-posterior direction. Thus, the 16 design and material properties of the haptics 104 and the optic portion 102 can allow the 17 adjustable AIOL 100 to maintain a high degree of sensitivity to radial forces applied to the 18 haptics 104 by capsular bag reshaping caused by ciliary muscle movements.
19 [0117] In some embodiments, the anterior element 106 can be configured such that the anterior optical surface 112 changes shape from a spherical surface configuration to an 21 aspherical surface configuration in response to fluid entering the optic fluid chamber 110. An 22 aspherical surface configuration can correct for high order aberrations such as spherical 23 aberration. The fluid can enter the optic fluid chamber 110 from one or more haptic fluid 24 chambers 120 coupled to the optic portion 102 in response to ciliary muscle movement.
[0118] The anterior optical surface 112 can be stressed into the aspherical surface 26 configuration as a center or central portion of the anterior element 106 flexes or bulges out 27 further than an outer periphery of the anterior element 106 which is held down by adhesives 28 148 or an adhesive layer (see Figs. 1B and 1C).
29 [0119] In other embodiments, the posterior element 108 can be configured such that the posterior optical surface 116 changes shape from a spherical surface configuration to an 31 aspherical surface configuration in response to fluid entering the optic fluid chamber 110.
1 [0120] The posterior optical surface 116 can be stressed into the aspherical surface 2 configuration as a center or central portion of the posterior element 108 flexes or bulges out 3 further than an outer periphery of the anterior element 106 which is held down by adhesives 4 148 or the adhesive layer.
[0121] The anterior element 106 can be attached or otherwise adhered to the posterior element 6 108 via adhesives 148 or an adhesive layer. The adhesive layer can be substantially annular-7 shaped. The adhesives 148 or adhesive layer can be positioned at a peripheral edge 150 (see 8 Fig. ID) of the optic portion 102 in between the anterior element 106 and the posterior element 9 108. For example, the adhesives 148 can be positioned on top of the raised inner surface 132 of the posterior element 108.
11 [0122] The adhesives 148 or adhesive layer can comprise or be made in part of a 12 biocompatible adhesive. The adhesives 148 or adhesive layer can comprise or be made in part 13 of a biocompatible polymeric adhesive.
14 [0123] The adhesives 148 or adhesive layer can comprise or be made in part of a cross-linkable polymer precursor formulation. The cross-linkable polymer precursor formulation can 16 comprise or be made in part of a copolymer blend, a hydmxyl-functional acrylic monomer, 17 and a photoinitiator.
18 [0124] The copolymer blend can comprise an alkyl acrylate (e.g., n-butyl acrylate in the 19 amount of about 41% to about 45% (wt%)), a fluoro-alkyl acrylate (e.g., trifluoroethyl methacrylate in the amount of about 20% to about 24% (wt%)), and a phenyl-alkyl acry late 21 (phenylethyl acrylate in the amount of about 28% to about 32% (wt%)).
The hydroxyl-22 functional acrylic monomer can be 2-hydroxyethyl acrylate (HEA).The photoinitiator can be 23 used to facilitate curing of the adhesive_ For example, the photoinitiator can be Darocur 4265 24 (a 50/50 blend of dipheny1(2,4,6-trimethylbenzoyflphosphine oxide and 2-hydroxy2-methylpropiophenone).
26 [0125] The first step in making the adhesive is preparation of a hydroxyl-functional polymer 27 precursor by photopolymerizing the cross-linkable polymer precursor formulation, thereby 28 yielding a cured composition. The second step is chemical conversion of the precursor 29 polymer pendant hydroxyl moieties, or hydroxyl pendant groups, into pendant methacrylate functional groups by reacting with a methacrylic anhydride or methacryloyl chloride, thus 31 forming a methacrylate-functional or methacrylic-functional cross-linkable polymer 1 comprising the alkyl acrylate or methacrylate (e.g., n-butyl acrylate), the fluoro-alkyl 2 (meth)acrylate (e.g., trifluoroethyl methacrylate), the phenyl-alkyl acrylate (phenylethyl 3 acrylate), and 2-(2-methyl-acryloyloxy)ethyl acrylate.
4 [0126] The methacrylic-functional cross-linkable polymer can be blended with a reactive acrylic monomer diluent such as 1-adamantyl methacrylate (ADMA) and the same 6 photoinitiator (e.g.. Darocur 4265). For example, the final composition of the adhesives 148 7 can comprise the cross-linkable polymer precursor formulation in the amount of about 50% to 8 about 85% (wt%) (e.g., about 61% to about 65%), the reactive acrylic monomer diluent in the 9 amount of about 10% to about 40% (wt%) (32% to about 36%), and the photoinitiator (e.g., Darocur 4265) in the amount of about 2% to about 3% (wt%).
11 [0127] The adhesives 148 or adhesive layer can bond, adhere, or otherwise join the anterior 12 element 106 to the posterior element 108. As will be discussed in more detail in the following 13 sections, the thickness of the adhesive layer can be adjusted post-implantation to adjust a base 14 power of the adjustable AIOL 100.
[0128] In some embodiments, the same adhesives 148 used to bond the anterior element 106 16 to the posterior element 108 can also be used to bond or affix the peripheral portion 103 (e.g., 17 the one or more haptics 104) to the optic portion 102.
18 [0129] In certain embodiments, the anterior optical surface 112 of the anterior element 106 can 19 be manufactured to have an aspherical optical surface prior to the adjustable AIOL 100 being implanted within the eye of the patient. In these embodiments, the anterior optical surface 112 21 can be aspheric regardless of any fluid pressure changes within the optic fluid chamber 110. In 22 these embodiments, the anterior optical surface 112 can also maintain its asphericity across all 23 base power changes.
24 [0130] In other embodiments, the posterior optical surface 116 of the posterior element 108 can be manufactured to have an aspherical optical surface prior to the adjustable AIOL 100 26 being implanted within the eye of the patient. In these embodiments, the posterior optical 27 surface 116 can be aspheric regardless of any fluid pressure changes within the optic fluid 28 chamber 110. In these embodiments, the posterior optical surface 116 can maintain its 29 asphericity across all base power changes.
[0131] In some embodiments, the anterior element 106 can have a thickness at its center or 31 central portion that is greater than a thickness at its periphery. In certain embodiments, the 1 posterior element 108 can also have a thickness at its center or central portion that is greater 2 than a thickness at its periphery.
3 [0132] As shown in Figs. 1B-1D, the optic portion 102 can have an optical axis 152. The 4 optical axis 152 can extend in an anterior-to-posterior direction through a center or center point of the optic portion 102. The optical axis 152 can extend through the centers or center points 6 of both the anterior element 106 and the posterior element 106.
7 [0133] The thickness of the anterior element 106 can be greater at the optical axis 152 or near 8 the optical axis 152 than at the periphery of the anterior element 106.
In some embodiments, 9 the thickness of the anterior element 106 can increase gradually from the periphery of the anterior element 106 toward the optical axis 152.
11 [0134] In certain embodiments, the thickness of the anterior element 106 at the optical axis 12 152 or near the optical axis 152 can be between about 0.45 mm and about 0.55 mm. In these 13 and other embodiments, the thickness of the anterior element 106 near the periphery can be 14 between about 0.20 mm and about 0.40 mm. This difference in thickness can contribute to the anterior optical surface 112 changing shape from a spherical surface configuration to an 16 aspherical surface configuration as fluid enters the fluid-filled optic fluid chamber 110 from 17 the haptic fluid chamber(s) 120.
18 [0135] Moreover, the anterior inner surface 114 of the anterior element 106 can have less 19 curvature or be flatter than the anterior optical surface 112. This difference in surface curvature between the anterior inner surface 114 and the anterior optical surface 112 can also 21 contribute to the anterior optical surface 112 changing shape from the spherical surface 22 configuration to the aspherical surface configuration as fluid enters the fluid-filled optic fluid 23 chamber 110 from the haptic fluid chamber(s) 120.
24 [0136] In other embodiments, the thickness of the posterior element 108 can be greater at the optical axis 152 or near the optical axis 152 than portions of the posterior element 108 radially 26 outward from the optical axis 152 but prior to reaching the raised inner surface 132. The 27 thickness of the posterior element 108 can gradually decrease from the optical axis 152 to 28 portions radially outward from the optical axis 152 (but prior to reaching the raised inner 29 surface 132). The thickness of the posterior element 108 can increase again from the beginning of the raised inner surface 132 to the peripheral edge 150.
1 [0137] In certain embodiments, the thickness of the posterior element 108 at the optical axis 2 152 or near the optical axis 152 can be between about 0.45 mm and about 0.55 mm. In these 3 and other embodiments, the thickness of the posterior element 108 radially outward from the 4 optical axis 152 (but prior to reaching the raised inner surface 132) can be between about 0.20 mm and about 0.40 mm. The thickness of the posterior element 108 near the peripheral edge 6 150 can be between about 1.00 mm and 1.15 mm. This difference in thickness can contribute 7 to the posterior optical surface 116 changing shape from the spherical surface configuration to 8 the aspherical surface configuration as fluid enters the fluid-filled optic fluid chamber 110 9 from the haptic fluid chamber(s) 120.
[0138] Moreover, the posterior inner surface 118 of the posterior element 108 can have less 11 curvature or be flatter than the posterior optical surface 116. This difference in surface 12 curvature between the posterior inner surface 118 and the posterior optical surface 116 can 13 also contribute to the posterior optical surface 116 changing shape from the spherical surface 14 configuration to the aspherical surface configuration as fluid enters the fluid-filled optic fluid chamber 110 from the haptic fluid chamber(s) 120.
16 [0139] Fig. 2A is a graphic representation of a composite material 200 comprising a composite 17 base material 202, an energy absorbing constituent 204, and a plurality of expandable 18 components 206. In some embodiments, the optic portion 102 of the adjustable AIOL 100 can 19 be made in part of the composite material 200. In other embodiments, the peripheral portion 103 of the adjustable AIOL 100 can be made in part of the composite material 200. In further 21 embodiments, both the optic portion 102 and the peripheral portion 103 of the adjustable 22 AIOL 100 can be made in part of the composite material 200.
23 [0140] The composite base material 202 can comprise a methacrylate-functional or 24 methacrylic-functional cross-linkable polymer and reactive acrylic monomer diluents including lauryl methacrylate (n-dodecyl methacrylate or SR313) and ADMA. By controlling 26 the amount of lauryl methacrylate (SR313) to ADMA, the overall corresponding hardness (i.e., 27 more ADMA) or softness (i.e., more SR313) of the cured composite material 200 can be 28 controlled. The methacrylate-functional or methacrylic-functional cross-linkable polymer can 29 be made using the cross-linkable polymer precursor formulation. The cross-linkable polymer precursor formulation can be the same cross-linkable polymer precursor formulation used as 31 part of the formulation for the adhesives 148.
1 [0141] As previously discussed, the optic portion 102 can comprise or be made in pan of the 2 lens body material. Also, as previously discussed, the peripheral portion 103 (e.g., the one or 3 more haptics 104) can comprise or be made in part of the haptic material.
The cross-linkable 4 polymer precursor formulation can comprise the same copolymer blend used to make the lens body material, the haptic material, or the adhesives.
6 [0142] The copolymer blend can comprise an alkyl acrylate or methacrylate (e.g., n-butyl 7 acrylate), a fluom-alkyl (meth)acrylate (e.g., trifluoroethyl methacrylate), and a phenyl-alkyl 8 acrylate (e.g., phenylethyl acrylate). For example, the copolymer blend can comprise n-butyl 9 acrylate in the amount of about 41% to about 45% (wt%), tfifluoroethyl methacrylate in the amount of about 20% to about 24% (wt%), and phenylethyl acrylate in the amount of about 11 28% to about 32% (wt%). As previously discussed, the cross-linkable polymer precursor 12 formulation can comprise or be made in part of the copolymer blend, a hydroxyl-functional 13 acrylic monomer (e.g., HEA), and a photoinitiator (e.g., Darocur 4265 or a 50/50 blend of 14 dipheny1(2,4,6-trimethylbenzoy1)-phosphine oxide and 2-hydroxy2-methylpropiophenone).
[0143] The composite base material 202 can comprise the methacrylate-functional or 16 methacrylic-functional cross-linkable polymer (as discussed above) in the amount of about 17 50% to about 65% (e.g., about 55% to about 60%) (wt%), the reactive acrylic monomer 18 diluent lauryl methacrylate (SR313) in the amount of about 32% to about 38% (e.g., about 19 32.70%) (wt%), the reactive acrylic monomer diluent adamantly methacrylate (ADMA) in the amount of about 5% to about 9% (e.g., about 7.30%) (wt%).
21 [0144] The composite material 200 can be made in several operations. The first operation can 22 comprise preparing an uncolored composite base material 202. The second operation can 23 comprise mixing the composite base material 202 with an energy absorbing constituent 204, 24 expandable components 206, and initiators such as one or more photoinitiators, thermal initiators, or a combination thereof. The third operation can comprise placing the uncured 26 composite material 200 into a desired location within the optic portion 102, the haptic(s) 104, 27 or a combination thereof, and curing the composite material 200 in place to form the adhered 28 composite material 200.
29 [0145] For example, the uncolored composite base material 202 can be mixed with an energy absorbing constituent 204 such as a dye (e.g., Disperse Red 1 dye) or pigment (graphitized 31 carbon black). The energy absorbing constituent 204 will be discussed in more detail below.
1 [0146] In some embodiments, the expandable components 206 can make up about 5.0% to 2 about 15.0% by weight of a final formulation of the composite material 200. More specifically, 3 the expandable components 206 can make up about 8.0% to about 12.0%
(e.g., about 10.0%) 4 by weight of a final formulation (see Table 1) of the composite material 200. In these and other embodiments, the energy absorbing constituent 204 can make up about 0.044% to about 6 0.44% (or about 0.55%) by weight of the final formulation of the composite material 200.
7 [0147] The photoinitiator can be Omnirad 2022 (bis(2,4,6-trimethylbenzoyl)phenyl-8 phosphineoxide/2-hydroxy-2-methyl-1- phenyl-propari-l-one). The photoinitiator can make up 9 about 1.30% by weight of a final formulation of the composite material 200 (see, e.g., Table 1). In addition, the composite material 200 can also comprise a thermal initiator. The thermal 11 initiator can make up about 1.00% by weight of a final formulation of the composite material 12 200 (see, e.g., Table 1). In some embodiments, the thermal initiator can be a dialkyl peroxide 13 such as Luperox peroxide. In other embodiments, the thermal initiator can be Perkadox.
14 [0148] Table 1 below provides an example formulation for the composite material 200:
TABLE 1: FORMULATION OF COMPOSITE MATERIAL (WT%) Cross-linkable polymer (in two 1.47% 2-hydroxyethyl acrylate (HEA) steps from precursor 1.96% Darocur 4265 (photoinitiator) formulation, as described above) 43.50% n-butylacrylate (nBA) 30.21% 2-phenylethylacrylate (PEA) 22.87% 2,2,2-trifluoroethylmethacrylate (TFEMA) Composite base material 60.00% cross-linkable polymer 32.70% lauryl methacrylate (SR313) 130% 1-adamantyl methacrylate (ADMA) Composite base material with 99.50% composite base material red energy absorbing colorant 0.50% Disperse Red 1 dye Composite base material with 99.95% composite base material black energy absorbing colorant 0.05% graphitized mesoporous carbon black Final formulation of 87.70% composite base material with red or black energy composite material absorbing colorant 10.00% expandable microspheres 1.00% Luperox peroxide (thermal initiator) 1.30% Omnirad 2022 2 [0149] Fig 2B illustrates that the expandable components 206 can be expandable microspheres 3 comprising an expandable thermoplastic shell 208 and a blowing agent 210 contained within 4 the expandable thermoplastic shell 208. The microspheres can be configured to expand such that a diameter 212 of at least one of the microspheres can increase about 2X
the original 6 diameter. In other embodiments, the microspheres can be configured to expand such that the 7 diameter 212 of at least one of the microspheres can increase about 4X or four times the 8 original diameter. In further embodiments, the microspheres can be configured to expand such 9 that the diameter 212 of at least one of the microspheres can increase between about 2X and about 4X (or about 35X) the original diameter. For example, the microspheres can have a 11 diameter 212 of about 12 pm at the outset. In response to an external energy applied or 12 directed at the composite material 200 or in response to energy transferred or transmitted to the 13 microspheres, the diameter 212 of the microspheres can increase to about 40 pm.
14 [0150] The volume of at least one of the microspheres can be configured to expand between about ten times (10X) to about 50 times (50X) in response to the external energy applied or 16 directed at the composite material 20 or in response to energy transferred or transmitted to the 17 microspheres.
18 [0151] In some embodiments, the blowing agent 210 can be an expandable fluid, such as an 19 expandable gas. More specifically, the blowing agent 210 can be a branched-chain hydrocarbon. For example, the blowing agent 210 can be isopentane. In other embodiments, 21 the blowing agent 210 can be or comprise cyclopentane, pentane, or a mixture of 22 cyclopentane, pentane, and isopentane.
23 [0152] Fig. 213 illustrates that each of the expandable components 206 can comprise a 24 thermoplastic shell 208. Fig. 2B also illustrates that a thickness of the thermoplastic shell 208 can change as the expandable component 206 increases in size. More specifically, the 26 thickness of the thermoplastic shell 208 can decrease as the expandable component 206 27 increases in size. For example, when the expandable components 206 are expandable 28 microspheres, the thickness of the thermoplastic shell 208 (i.e., its thickness in a radial 29 direction) can decrease as the diameter 212 of the expandable microsphere increases.
[0153] For example, as previously discussed, at least one of the expandable microspheres can 31 have a diameter 212 of about 12 pm at the outset. In this embodiment, the thermoplastic shell 1 208 of the expandable microsphere can have a shell thickness of about 2.0 pm. In response to 2 an external energy applied or directed at the composite material 200 or in response to energy 3 transferred or transmitted to the microsphere, the diameter 212 of the microsphere can increase 4 to about 40 pm (and the volume expand between about 10X and 50X) and the shell thickness of the microsphere can decrease to about 0.1 pm.
6 [0154] Although Figs. 2A and 213 illustrate the expandable components 206 as spheres or 7 microspheres, it is contemplated by this disclosure that the expandable components 206 can be 8 substantially shaped as ovoids, ellipsoids, cuboids or other polyhedrons, or a combination 9 thereof.
[0155] In some embodiments, the thermoplastic shell 208 can be made in part of nitriles or 11 acrylonitrile copolymers. For example, the thermoplastic shell 208 can be made in part of 12 acrylonitrile, styrene, butadiene, methyl acrylate, or a combination thereof.
13 [0156] As previously discussed, the expandable components 206 can make up between about 14 8.0% to about 12% by weight of a final formulation of the composite material 200. The expandable components 206 can make up about 10% by weight of a final formulation of the 16 composite material 200.
17 [0157] The expandable components 206 can be dispersed or otherwise distributed within the 18 composite base material 202 making up the bulk of the composite material 200. The composite 19 base material 202 can serve as a matrix for holding or carrying the expandable components 206. The composite material 200 can expand in response to an expansion of the expandable 21 components 206 (e.g., the thermoplastic microspheres). For example, a volume of the 22 composite material 200 can increase in response to the expansion of the expandable 23 components 206.
24 [0158] The composite material 200 also comprises an energy absorbing constituent 204. In some embodiments, the energy absorbing constituent 204 can be an energy absorbing colorant.
26 [0159] In certain embodiments, the energy absorbing colorant can be an energy absorbing dye.
27 For example, the energy absorbing dye can be an azo dye. In some embodiments, the azo dye 28 can be a red azo dye such as Disperse Red 1 dye. In other embodiments, the azo dye can be an 29 orange azo dye such as Disperse Orange dye (e.g., Disperse Orange 1), a yellow azo dye such as Disperse Yellow dye (e.g., Disperse Yellow 1), a blue azo dye such as Disperse Blue dye 31 (e.g., Disperse Blue 1), or a combination thereof.
1 [0160] In additional embodiments, the energy absorbing colorant can be or comprise a 2 pigment. For example, the energy absorbing colorant can be or comprise graphitized carbon 3 black as the pigment.
4 [01611 Similar to the expandable components 206, the energy absorbing constituent 204 can be dispersed or otherwise distributed within the composite base material 202 making up the 6 bulk of the composite material 200. The composite base material 202 can serve as a matrix for 7 holding or carrying the expandable components 206 and the energy absorbing constituent 204.
8 [0162] As previously discussed, the energy absorbing constituent 204 can make up between 9 about 0.025% to about 1.0% (or, more specifically, about 0.045% to about 0.45%) by weight of a final formulation of the composite material 200. For example, when the energy absorbing 11 constituent 204 is a dye (e.g., an azo dye such as Disperse Red 1), the energy absorbing 12 constituent 204 can make up about between about 0.45% to about 1.0% by weight of a final 13 formulation of the composite material 200. When the energy absorbing constituent 204 is 14 graphitized carbon black or other types of pigments, the energy absorbing constituent 204 can make up about 0.025% to about 0.045% by weight of a final formulation of the composite 16 material 200.
17 [0163] The energy absorbing constituent 204 (e.g., azo dye, graphitized carbon black, or a 18 combination thereof) can absorb or capture an external energy applied or directed at the 19 composite material 200. The energy absorbing constituent 204 can absorb or capture the external energy and then transform or transfer the energy into thermal energy or heat to the 21 expandable components 206.
22 [0164] The thermoplastic shell 208 can soften and begin to flow as thermal energy is 23 transferred or transmitted to the expandable components 206. The thermoplastic shell 208 of 24 the expandable components 206 can then begin to thin or reduce in thickness in response to the thermal energy transferred or transmitted to the expandable components 206. As the 26 thermoplastic shell 208 begins to soften and reduce in thickness, the blowing agent 210 within 27 the expandable components 206 can expand. The blowing agent 210 can also expand in 28 response to the thermal energy or heat transferred or transmitted to the expandable components 29 206. Expansion of the blowing agents 210 can cause the expandable components 206 (e.g., the thermoplastic microspheres) to expand or increase in volume. This ultimately causes the 31 composite material 200 to expand or increase in volume.
1 [0165] The composite material 200 can expand or increase in size in an isotropic manner such 2 that the composite material 200 expands in all directions. Such isotropic expansion can be 3 harnessed to produce expansion or material displacement in specific directions by placing or 4 positioning the composite material 200 at specific locations along the haptic(s) 104 or optic portion 102 of the adjustable AIOL 100.
6 [0166] As will be discussed in more detail in the following sections, in some embodiments, 7 the external energy can be light energy and the energy absorbing constituent 204 can absorb or 8 capture the light energy directed at the composite material 200 and transform or transfer the 9 light energy into thermal energy or heat to the expandable components 206. The blowing agent 210 within the expandable components 206 can expand or become energized in response to the 11 thermal energy or heat. The expandable components 206 and, ultimately, the composite 12 material 200 can expand or increase in volume in response to this light energy directed at the 13 composite material 200.
14 [0167] The shape change (e.g., increase in volume) undertaken by the expandable components 206 can be a persistent change or a substantially permanent change. A
persistent change or 16 substantially permanent change can mean that the expandable components 206 do not 17 substantially revert back to its original shape or size after the shape change (e.g., after an 18 increase in volume) has occurred. As a result, any change in the size or volume of the 19 composite material 200 caused by a change in the size or volume of the expandable components 206 is also persistent or substantially permanent. As will be discussed in more 21 detail in the following sections, this means that any structural changes made to the adjustable 22 AIOL 100 as a result of external energy or stimulus applied or otherwise directed at the 23 composite material 200 embedded or integrated within the adjustable AIOL
100 can persist or 24 remain substantially permanent.
[0168] The thermoplastic shells 208 of the expandable components 206 can harden, once 26 again, when the external energy is no longer directed or applied to the composite material 200.
27 The thermoplastic shells 208 of the expandable components 206 can harden, once again, when 28 the temperature within a vicinity of the expandable components 206 falls below a certain 29 threshold. For example, the thermoplastic shells 208 of the expandable microspheres can harden when light energy is no longer directed at the composite material 200.
After the 1 thermoplastic shells 208 harden, the expandable components 206 are locked into their new size 2 and expanded configuration.
3 [0169] When the energy absorbing constituent 204 is an energy absorbing colorant, such as a 4 dye or graphitized carbon, the color of at least part of the composite material 200 can take on the color of the energy absorbing colorant. For example, when the energy absorbing 6 constituent 204 is an azo dye such as Disperse Red 1 having a red color, at least a portion of 7 the composite material 200 comprising the energy absorbing constituent 204 can be colored 8 red. Moreover, when the energy absorbing constituent 204 is graphitized carbon having a 9 black color, at least a portion of the composite material 200 comprising the energy absorbing constituent 204 can be colored black. Although two colors (e.g., red and black) are mentioned 11 in this disclosure, it is contemplated by this disclosure and it should be understood by one of 12 ordinary skill in the art that energy absorbing colorant of other types of colors can also be used 13 such as energy absorbing yellow, orange, or blue dyes or materials.
14 [0170] The color of the energy absorbing colorant can be visually perceptible to a clinician or another medical professional when the adjustable AIOL 100 is made in part of the composite 16 material 100 comprising the energy absorbing colorant. The color of the energy absorbing 17 colorant can be visually perceptible to a clinician or another medical professional when the 18 adjustable AIOL 100 is implanted within an eye of a patient. For example, the composite 19 material 200 can comprise Disperse Red 1 serving as the energy absorbing colorant. In this example, at least part of the adjustable AIOL 100 can appear red to the clinician or another 21 medical professional when the adjustable AIOL 100 is implanted within the eye of a patient.
22 [0171] The color of the energy absorbing colorant can allow the clinician or another medical 23 professional detect or determine the location or position of the composite material 200 within 24 the adjustable AIOL 100. The color of the energy absorbing colorant can also allow the clinician or another medical professional to determine where to direct the external energy or 26 stimulus to adjust the adjustable AIOL 100.
27 [0172] As will be discussed in more detail in the following sections, at least part of the 28 adjustable AIOL 100 can be made of a composite material 200 comprising an energy 29 absorbing constituent 204 of a first color (e.g., red) and another part of the adjustable AIOL
100 can be made of additional composite material 200 comprising an energy absorbing 31 constituent 204 of a second color (e.g., black). By designing the adjustable AIOL 100 in this 1 manner, a clinician or another medical professional can direct external energy or stimulus at 2 different parts of the adjustable AIOL 100 using the different colors of the composite materials 3 200 as guides or markers for distinguishing between different locations of such target sites.
4 Moreover, the different colored composite materials 200 can also serve as indicators or visual cues as to where to direct the external energy or stimulus to cause certain changes in one or 6 more optical parameters (e.g., the base power, the cylindricity, or a combination thereof) of the 7 adjustable AIOL 100.
8 [0173] One technical problem faced by the applicants is how to integrate an adjustable 9 composite material into an optic portion and a peripheral portion (e.g., the haptics) of an AIOL
such that the adjustable composite material would adhere to the lens material used to make the 11 rest of the AIOL and remain substantially fixed at certain locations within the optic portion or 12 peripheral portion. One solution discovered by the applicants and disclosed herein is the 13 unique composition of the composite material which incorporates the same copolymer blend 14 used to make the lens body material and the haptic material. Moreover, the composite material is made in part in the cross-linkable polymer precursor formulation used in the adhesive for 16 adhering parts of the AIOL to one another_ By designing the AIOL in this manner, the 17 composite material is compatible with the rest of the material used to construct the optic 18 portion and the peripheral portion and remains substantially fixed at its location without 19 migrating or shifting.
[0174] Another technical problem faced by the applicants is how to ensure that any 21 adjustments made to the AIOL persist long after the adjustment procedure. One solution 22 discovered by the applicants and disclosed herein is to induce an expansion of a composite 23 material made in part of expandable microspheres comprising a blowing agent contained 24 within thermoplastic shells. The thermoplastic shells can soften (and the thickness of the thermoplastic shells can decrease) in response to an external energy directed or applied at the 26 composite material (which can result in heat or thermal energy being transferred or transmitted 27 to the expandable microspheres). The blowing agent within the thermoplastic shells can 28 expand as the thermoplastic shells soften. Expansion of the blowing agent can expand the 29 microspheres, which can, in turn, expand the composite base material serving as the bulk of the composite material. The expandable microspheres can retain their new enlarged or 1 expanded configuration even after the external energy is no longer applied to the composite 2 material.
3 [0175] Moreover, the composite material also comprises an energy absorbing constituent such 4 as an energy absorbing dye or colorant. The energy absorbing constituent can capture or absorb a relatively harmless external energy or stimulus directed at the composite material and 6 transform or transfer the external energy into thermal energy which can then cause the 7 thermoplastic microspheres to expand. By designing the adjustable AIOL
100 in this manner, 8 one or more bursts or pulses of relatively harmless energy or stimulus (e.g., light energy) can 9 be used to induce a persistent change in the shape or size of at least part of the adjustable AIOL 100. This persistent change in the shape or size of the adjustable AIOL
100 can have a 11 continuing effect on an optical parameter of the lens including, for example, its base power.
12 [0176] Figs. 3A and 3B illustrate sectional views of an embodiment of the adjustable AIOL
13 100 comprising an expandable spacer 300 made at least in part of the composite material 200.
14 The expandable spacer 300 can be positioned or otherwise disposed in a radially inner portion 146 of the peripheral portion 103 (e.g., a haptic 104) of the adjustable AIOL
NO.
16 [0177] As shown in Figs. 3A and 313, the radially inner portion 146 of the haptic 104 can be 17 radially thicker or bulkier than the radially outer portion 144. Figs.
3A and 3B also illustrate 18 the adjustable AIOL 100 as being implanted within an eye of a patient and, more specifically, 19 as being positioned within a capsular bag 304 of the patient (shown in Figs. 3A and 3B using broken lines). The radially outer portion 144 of the haptic 104 can come into physical contact 21 or push against an inner surface of the capsular bag 304 when the adjustable AIOL 100 is 22 positioned within the capsular bag 304.
23 [0178] As shown in Figs. 3A and 313, the expandable spacer 300 can be positioned partially 24 within the radially inner portion 146 of the haptic 104. In some embodiments, at least part of the expandable spacer 300 can jut out or extend out radially inward or laterally toward the 26 outer peripheral surface 142 of the optic portion 102. In these and other embodiments, at least 27 part of the expandable spacer 300 can be positioned in between the haptic 104 and the optic 28 portion 102. More specifically, the expandable spacer 300 can be positioned in between (e.g., 29 radially in between) the optic portion 102 and the haptic fluid chamber 120.
[0179] In some embodiments, the expandable spacer 300 can be adhered to the radially inner 31 portion 146 of the haptic 104 by being cured into place. For example, the expandable spacer 1 300 can be adhered to a furrow, indentation, or groove formed along the radially inner portion 2 146.
3 [0180] In other embodiments, the expandable spacer 300 can be positioned entirely within the 4 radially inner portion 146 of the haptic 104. In some embodiments, a cavity, conduit, or other void space can be formed within the radially inner portion 146 and the expandable spacer 300 6 can be introduced into the cavity, conduit, or void space and cured into place.
7 [0181] In further embodiments, the expandable spacer 300 can refer to part of the peripheral 8 portion 103 (e.g., the haptic 104) made of the composite material 200.
For example, the 9 expandable spacer 300 can refer to part of the radially inner portion 146 of the haptic 104 made of the composite material 200.
11 [0182] Although Figs. 3A and 3B illustrate the expandable spacer 300 as having a rectangular 12 cross-sectional profile, it is contemplated by this disclosure and it should be understood by one 13 of ordinary skill in the art that the cross-sectional profile of the expandable spacer 300 can be 14 substantially shaped as an oval, a circle, triangular or another polygon.
[0183] Figs. 3A and 3B also illustrate that an external energy 302 can be directed or otherwise 16 applied to the expandable spacer 300 to induce a shape change in the expandable spacer 300 17 (e.g., enlarge the expandable spacer 300) to affect an optical parameter of the adjustable AIOL
18 100.
19 [0184] In some embodiments, the external energy 302 can be light energy.
More specifically, the external energy 302 can be laser light. In certain embodiments, the laser light can have a 21 wavelength between about 488 nm to about 650 nm. The external energy 302 can be one or 22 more bursts or pulses of laser light.
23 [0185] In some embodiments, the laser light can be green laser light.
The green laser light can 24 have a wavelength of between about 520 nm to about 570 nm. In one example, embodiment, the external energy 302 can be green laser light having a wavelength of about 532 nm.
26 [0186] For example, the laser light can be laser light emitted by an ophthalmic laser. For 27 example, the laser light can be laser light emitted by a retinal coagulation laser.
28 [0187] When the external energy 302 is light energy, the energy absorbing constituents 204 29 can absorb or otherwise capture the light energy and convert the light energy into thermal energy to cause the expandable components 206 within the composite material 200 to expand.
1 [0188] As shown in Fig. 3B, the external energy 302 can cause the expandable spacer 300 to 2 expand. Expansion of the expandable spacer 300 can cause the spacer 300 to push against the 3 outer peripheral surface 142 of the optic portion 102. For example, the enlarged expandable 4 spacer 300 can push against the posterior element 108 of the optic portion 102. Since the periphery of the posterior element 108 is relatively thick or bulky in between the outer 6 peripheral surface 142 and the raised inner surface 132, the enlarged expandable spacer 300 7 primarily exerts a radially outward force or laterally outward force on the haptic 104.
8 [0189] Fig. 3B illustrates that the haptic 104 can be biased or pushed against the sides of the 9 capsular bag 304. More specifically, the enlarged expandable spacer 300 can bias or push the radially inner portion 146 of the haptic 104 radially outward. For example, Fig. 3B illustrates 11 the radially outward displacement of the radially inner portion 146 of the haptic 104 using 12 solid lines to indicate the position of the radially inner portion 146 after the expansion and 13 broken-lines to indicate the position of the radially inner portion 146 prior to the expansion.
14 Given the limited amount of space within the capsular bag 304, this radially outward displacement of the radially inner portion 146 of the haptic 104 can cause the chamber walls of 16 the haptic fluid chamber 120 to compress or squeeze together, thereby decreasing a volume of 17 the haptic fluid chamber 120.
18 [0190] As previously discussed, both the haptic fluid chamber(s) 120 and the optic fluid 19 chamber 110 can be filled with a fluid (e.g., silicone oil). Decreasing the volume of the haptic fluid chamber 120 can cause at least some of the fluid within the haptic fluid chamber(s) 120 21 to flow from the haptic fluid chamber(s) 120 into the optic fluid chamber 120. Moreover, as 22 previously discussed, the haptic fluid chamber(s) 120 can be in fluid communication with the 23 optic fluid chamber 120 through a plurality of fluid channels 122 (including the first pair of 24 fluid channels 122A, the second pair of fluid channels 122B, or a combination thereof, see Fig.
1A). Although fluid flow between the haptic fluid chamber 120 and the optic fluid chamber 26 120 is shown in Fig. 3B using the curved arrow depicted using broken-lines, it should be 27 understood by one of ordinary skill in the art that fluid flows from the haptic fluid chamber(s) 28 120 to the optic fluid chamber 120 via the plurality of fluid channels 122.
29 [0191] As previously discussed, the base power of the optic portion 102 can be configured to change based on an internal fluid pressure within the fluid-filled optic fluid chamber 110. The 1 base power of the optic portion 102 can be configured to increase as fluid enters the optic fluid 2 chamber 110 from the haptic fluid chamber(s) 120.
3 [0192] The optic portion 102 can also be configured to change shape in response to fluid 4 entering the optic fluid chamber 110. In certain embodiments, the anterior element 106 of the optic portion 102 can be configured to change shape (e.g., increase its curvature) in response to 6 the fluid entering the optic fluid chamber 110. In other embodiments, the posterior element 7 108 of the optic portion 102 can be configured to change shape (e.g., increase its curvature) in 8 response to the fluid entering the optic fluid chamber 110. In further embodiments, both the 9 anterior element 106 and the posterior element 108 can be configured to change shape in response to the fluid entering the optic fluid chamber 110. The base power of the optic portion 11 102 can be configured to increase in response to the shape change(s) undertaken by the 12 anterior element 106, the posterior element 108, or a combination thereof.
13 [0193] As depicted in Figs. 3A and 3B, when the expandable spacer 300 is positioned in 14 between the optic portion 102 and the haptic fluid chamber(s) 120, applying an external energy 302 to the expandable spacer 300 can cause an interaction between the haptic(s) 104 and a 16 capsular environment (e.g., the sides of the capsular bag 304) surrounding the haptic(s) 104.
17 This interaction between the haptic(s) 104 and the capsular environment can result in an 18 increase of the base power of the adjustable AIOL 100.
19 [0194] For example, adjusting a base power of the adjustable AIOL 100 can comprise directing or applying an external energy 302 (e.g., light energy between about 520 nm to about 21 570 nm) at the adjustable AIOL 100 implanted within an eye of the patient. More specifically, 22 the external energy 302 can be applied or directed at an expandable spacer 300 made in part of 23 the composite material 200. The expandable spacer 300 can expand in response to the 24 application of the external energy 302. Expansion of the spacer 300 can result in the haptic(s) 104 being pushed or biased radially or laterally outward against the sides of the capsular bag 26 304. This can result in the walls of the haptic fluid chamber 120 being compressed or squeezed 27 together such that a volume of the haptic fluid chamber 120 is reduced.
Fluid within the haptic 28 fluid chamber(s) 120 can then flow into the optic fluid chamber 110 in response to this 29 reduction in the volume of the haptic fluid chamber(s) 120. The base power of the optic portion 102 can increase in response to this fluid flow into the optic fluid chamber 110.
1 [0195] In some embodiments, bursts or pulses of external energy 302 (e.g., light energy) 2 directed at the expandable spacer 300 can result in an increase in the base power of the 3 adjustable AIOL 100 by between about +0.10 D and about +0.20 D (e.g., about +0.125 D). For 4 example, pulses of green laser light directed at the expandable spacer 300 can result in an increase in the base power of the adjustable AIOL 100 by between about +0.10 D
and about 6 +0.20 D (e.g., about +0.125 D). In some embodiments, the base power of the adjustable AIOL
7 100 can increase between about +1.0 D to about +5.0 D (e.g., about +2.0 D) in total in 8 response to bursts or pulses of the external energy 302 directed at the expandable spacer 300.
9 [0196] Figs. 4A and 4B are top and sectional views, respectively, of an embodiment of the adjustable AIOL 100 comprising the expandable spacer 300 extending radially inward toward 11 the optic portion 102 and occupying a gap space 400 in between the haptic(s) 104 and the optic 12 portion 102.
13 [0197] The adjustable AIOL 100 can be implanted within the capsular bag 304 (see Figs. 3A
14 and 3B) of the patient when positioned according to the configuration shown in Fig. 4A. The haptics 104 of the adjustable AIOL 100 can be curved around a periphery of the optic portion 16 102 with the free ends of the haptics 104 on almost opposing sides of the optic portion 102_ 17 [0198] As shown in Fig. 4A, the expandable spacer 300 can also be curved such that a radially 18 inward portion of the expandable spacer 300 follows or matches a curvature of the optic 19 portion 102. The expandable spacer 300 can extend along almost an entire length of each of the haptics 104.
21 [0199] Fig. 4B illustrates that the expandable spacer 300 can extend radially inward from the 22 radially inner portion 146 of the haptics 104 toward the optic portion 102. In some 23 embodiments, the expandable spacer 300 can be formed as a fin-like protrusion extending 24 radially inward from the radially inner portion 146 of the haptics 104.
In other embodiments, the expand spacer 300 can be substantially shaped as discontinuous segments of an annulus 26 positioned, at least partly, in between the optic portion 102 and the haptics 104.
27 [0200] As illustrated in Fig. 4B, the expandable spacer 300 can have an anterior-to-posterior 28 height. The anterior-to-posterior height of the expandable spacer 300 can be significantly less 29 than the anterior-to-posterior height of the haptic 104. Moreover, the expandable spacer 300 is relatively unconstrained in the anterior and posterior directions such that any expansion of the 31 spacer 300 primarily exerts a radially outward force or pressure on the haptics 104. Such 1 expansion exerts relatively little force or pressure on the haptics 104 in the anterior-to-2 posterior direction.
3 [0201] In some embodiments, the expandable spacer 300 can have a spacer anterior-to-4 posterior height of between about 0.10 mm to about 1.00 mm. The expandable spacer 300 can also have a spacer radial width. The spacer radial width can be between about 0.50 mm to 6 about 1.0 mm. In comparison, the haptic fluid chamber 120 can have a haptic fluid chamber 7 anterior-to-posterior height of between about 2.0 mm to about 3.0 mm.
Moreover, the haptic 8 fluid chamber 120 can have a haptic fluid chamber radial width of between about 0.8 mm to 9 about 1.1 mm.
[0202] Figs. 5A and 5B illustrate sectional views of another embodiment of the adjustable 11 AIOL 100 comprising an expandable spreader 500 made at least in part of the composite 12 material 200. The expandable spreader 500 can be positioned or otherwise disposed in the 13 radially inner portion 146 of the peripheral portion 103 (e.g., the haptic(s) 104, as shown in 14 Figs. 5A and 513). The radially inner portion 146 of the haptic(s) 104 can be radially thicker or builder than the radially outer portion 144.
16 [0203] As shown in Figs. SA and 5B, the expandable spreader 500 can be positioned within a 17 channel 502 or opening defined within the radially inner portion 146 of the haptic 104. In 18 some embodiments, the channel 502 or opening can extend along the entire length of the 19 haptic 104. In other embodiments, the channel 502 or opening can extend partly along the length of the haptic 104. The channel 502 or opening can be in fluid communication with the 21 haptic fluid chamber 120.
22 [0204] In some embodiments, the expandable spreader 500 can occupy all of the space within 23 the channel 502 or opening except for a gap 504 or void space between the expandable 24 spreader 500 and the outer peripheral surface 142 of the optic portion 102. In further embodiments, the gap 504 or void space can be replaced with the haptic material.
26 [0205] In other embodiments, the expandable spreader 500 can occupy at least some of the 27 space within the channel 502 (for example, the expandable spreader 500 is positioned in a 28 radially middle portion of the channel 502 or opening). In these embodiments, a gap 504 or 29 void space or additional haptic material can separate (e.g., separate in a radial direction) the expandable spreader 500 from the outer peripheral surface 142 of the optic portion 102. In all 31 such embodiments, the expandable spreader 500 can be located or positioned such that 1 expansion of the expandable spreader 500 does not cause the radially inner portion 146 of the 2 haptic 104 or the expander spreader 500 to substantially impinge on or push against the outer 3 peripheral surface 142 of the optic portion 102 (thereby preventing the haptic(s) 104 from 4 being pushed against the sides of the capsular bag 304, which can cause deformation of the haptic(s) 104 and affect the volume of the haptic fluid chamber(s) 120). For example, the 6 expandable spreader 500 can be located or positioned such that expansion of the expandable 7 spreader 500 does not result in the squeezing together or compression of the haptic chamber 8 walls of the haptic fluid chamber 120 (or does not result in the reduction of the volume of the 9 haptic fluid chamber 120).
[0206] In some embodiments, the expandable spreader 500 can be adhered to the radially inner 11 portion 146 of the haptic 104 by being cured into place within the channel 502 or opening. For 12 example, the expandable spreader 500 can be adhered to a location or position at the middle 13 portion of the channel 502 or opening.
14 [0207] In further embodiments, the expandable spreader 500 can refer to part of the peripheral portion 103 (e.g., part of the haptic 104) made of the composite material 200.
For example, the 16 expandable spreader 500 can refer to part of the radially inner portion 146 of the haptic 104 17 made of the composite material 200.
18 [0208] Although Figs. 5A and 5B illustrate the expandable spreader 500 as having a 19 rectangular cross-sectional profile, it is contemplated by this disclosure and it should be understood by one of ordinary skill in the art that the cross-sectional profile of the expandable 21 spreader 500 can be substantially shaped as an oval, a circle, triangular or other polygon.
22 [0209] Figs. 5A and 5B illustrate that an external energy 302 can be directed or otherwise 23 applied to the expandable spreader 500 to induce a shape change in the expandable spreader 24 500 (e.g., enlarge the expandable spreader 500) to affect an optical parameter of the adjustable AIOL 100.
26 [0210] In some embodiments, the external energy 302 is light energy such as a laser light. In 27 certain embodiments, the laser light can have a wavelength between about 488 nm to about 28 650 nm. The external energy 302 can be one or more bursts or pulses of laser light. In some 29 embodiments, the laser light can be green laser light.
1 [0211] When the external energy 302 is light energy, the energy absorbing constituents 204 2 can absorb or otherwise capture the light energy and convert the light energy into thermal 3 energy to cause the expandable components 206 within the composite material 200 to expand.
4 [0212] As shown in Fig. 5B, the external energy 302 can cause the expandable spreader 500 to expand. Expansion of the expandable spreader 500 can cause the spreader 500 to push against 6 channel walls 506 of the channel 502 defined within the radially inner portion 146 of the 7 haptic 104.
8 [0213] Fig. 5B illustrates that the enlarged spreader 500 can expand or spread apart the 9 channel walls 506 to expand or spread apart the channel 502. Moreover, the enlarged spreader 500 can also deform the chamber walls of the haptic fluid chamber 120 by spreading apart at 11 least some of the chamber walls, thereby enlarging the volume of the haptic fluid chamber 12 120.
13 [0214] The enlarged expandable spreader 500 can bias or push apart the channel walls 506 of 14 the channel 502, at least in an anterior-to-posterior direction. This can result in an increase in the volume of the haptic fluid chamber 120. For example, Fig. 5B illustrates the spread apart 16 channel walls 506 and haptic chamber walls using solid lines and the position of the channel 17 walls 506 and haptic chamber walls prior to expansion using broken-lines. Fig. 5B also 18 illustrates that the gap 504 or void space in between the spreader 500 and the optic portion 102 19 allows the spreader 500 to expand or increase in size without causing the spreader 500 to impinge on or push against the outer peripheral surface 142 of the optic portion 102 (thereby 21 preventing the haptic(s) 104 from being pushed against the sides of the capsular bag 304, 22 which can cause deformation of the haptic(s) 104 and affect the volume of the haptic fluid 23 chamber(s) 120). In other embodiments, additional haptic material can separate the spreader 24 500 from the outer peripheral surface 142 of the optic portion 102 such that expansion of the spreader 500 only spreads apart the channel walls 506 and chamber walls and does not cause 26 the radially outer portion 144 of the haptic(s) 104 to push against the sides of the capsular bag 27 304.
28 [0215] As previously discussed, both the haptic fluid chamber(s) 120 and the optic fluid 29 chamber 110 can be filled with a fluid (e.g., silicone oil). Increasing the volume of the haptic fluid chamber 120 can cause at least some of the fluid within the optic fluid chamber 110 to 31 flow from the optic fluid chamber 110 into the haptic fluid chamber(s) 120. Moreover, as 1 previously discussed, the haptic fluid chamber(s) 120 can be in fluid communication with the 2 optic fluid chamber 120 through a plurality of fluid channels 122 (including the first pair of 3 fluid channels 122A, the second pair of fluid channels 122B, or a combination thereof, see Fig.
4 1A). Although fluid flow between the haptic fluid chamber 120 and the optic fluid chamber 120 is shown in Fig. 5B using the curved arrow depicted using broken-lines, it should be 6 understood by one of ordinary skill in the art that fluid flows from the optic fluid chamber 110 7 to the haptic fluid chamber(s) 120 via the plurality of fluid channels 122.
8 [0216] As previously discussed, the base power of the optic portion 102 can be configured to 9 change based on an internal fluid pressure within the fluid-filled optic fluid chamber 110. The base power of the optic portion 102 can be configured to decrease as fluid enters the haptic 11 fluid chamber(s) 120 from the optic fluid chamber 110.
12 [0217] The optic portion 102 can also be configured to change shape in response to fluid 13 exiting the optic fluid chamber 110. In certain embodiments, the anterior element 106 of the 14 optic portion 102 can be configured to change shape (e.g., decrease its curvature) in response to the fluid exiting the optic fluid chamber 110. In other embodiments, the posterior element 16 108 of the optic portion 102 can be configured to change shape (e.g., decrease its curvature) in 17 response to the fluid exiting the optic fluid chamber 110. In further embodiments, both the 18 anterior element 106 and the posterior element 108 can be configured to change shape in 19 response to the fluid exiting the optic fluid chamber 110. The base power of the optic portion 102 can be configured to decrease in response to the shape change(s) undertaken by the 21 anterior element 106, the posterior element 108, or a combination thereof.
22 [0218] As depicted in Figs. 5A and 5B, applying an external energy 302 to the expandable 23 spreader 500 (e.g., when the expandable spreader 500 is positioned within a channel 502 or 24 opening defined within the radially inner portion 146 of the haptic(s) 104) can cause the volume of the haptic fluid chamber(s) 120 to increase. This increase in the volume of the 26 haptic fluid chamber(s) 120 can draw fluid out of the optic fluid chamber 110 and cause a 27 decrease in the base power of the adjustable AIOL 100.
28 [0219] For example, a method of decreasing a base power of the adjustable AIOL 100 can 29 comprise directing or applying an external energy 302 (e.g., light energy between about 520 nm to about 570 nm) at an expandable spreader 500 embedded within the adjustable AIOL 100 31 implanted within an eye of the patient. More specifically, the external energy 302 can be 1 applied or directed at an expandable spreader 500 made in part of the composite material 200.
2 The expandable spreader 500 can expand in response to the application of the external energy 3 302. Expansion of the spreader 500 can result in the volume of the haptic fluid chamber(s) 120 4 being enlarged. Fluid within the optic fluid chamber 110 can then flow into the haptic fluid chamber(s) 110 in response to this increase in the volume of the haptic fluid chamber(s) 120.
6 The base power of the optic portion 102 can decrease in response to this fluid flow out of the 7 optic fluid chamber 110.
8 [0220] In some embodiments, bursts or pulses of external energy 302 (e.g., light energy) 9 directed at the expandable spreader 500 can result in a decrease in the base power of the adjustable AIOL 100 by between about -0.10 D and about -0.20 D (e.g., about -0.125 D). For 11 example, pulses of green laser light directed at the expandable spreader 500 can result in a 12 decrease in the base power of the adjustable AIOL 100 by between about -0.10 D and 13 about -0.20 D (e.g., about -0.125 D). In some embodiments, the base power of the adjustable 14 AIOL 100 can decrease between about -1.0 D to about -5.0 D (e.g., about -2.0 D) in total in response to bursts or pulses of the external energy 302 directed at the expandable spreader 500.
16 [0221] Fig. 6 illustrates a sectional view of another embodiment of the adjustable AIOL 100 17 comprising an expandable protuberance 600 made at least in part of the composite material 18 200. The expandable protuberance 600 can be positioned or otherwise disposed along part of 19 the radially inner portion 146 of the peripheral portion 103 (e.g., the one or more haptics 104) of the adjustable AIOL 100.
21 [0222] As shown in Fig. 6, the haptic 104 (e.g., any of the first haptic 104A or the second 22 haptic 104B) can comprise haptic chamber walls surrounding the haptic fluid chamber 120.
23 For example, the haptic chamber walls can comprise a radially inner wall 602 and radially 24 outer wall 604. The haptic fluid chamber 120 can be defined in part by the radially inner wall 602 and the radially outer wall 604.
26 [0223] The expandable protuberance 600 can be positioned or otherwise disposed along part 27 of the radially inner wall 602 of the haptic 104. More specifically, the expandable 28 protuberance 600 can be positioned or otherwise disposed or affixed along a radially outermost 29 portion 606 of the radially inner wall 602 of the haptic 104.
[0224] In some embodiments, the adjustable AIOL 100 can be designed such that a gap or 31 void space 608 radially separates the radially inner wall 602 of the haptic 104 from the outer 1 peripheral surface 142 of the optic portion 102. This can ensure that neither the expandable 2 protuberance 600 nor the radially inner wall 602 impinges or pushes against the outer 3 peripheral surface 142 of the optic portion 102 when the expandable protuberance 600 expands 4 (thereby preventing the haptic(s) 104 from being pushed against the sides of the capsular bag 304, which can cause deformation of the haptic(s) 104 and affect the volume of the haptic fluid 6 chamber(s) 120). As previously discussed, when the radially inner portion 146 of the haptic 7 104 pushes against the outer peripheral surface 142 of the optic portion 102, the haptic 8 chamber walls can compress or squeeze together as a result of the radially outer wall 604 of 9 the haptic 104 pressing against the sides of the capsular bag 304 of the patient. In other embodiments, the adjustable AIOL 100 can be designed such that the radially inner wall 602 11 of the haptic 104 continuously rests against the outer peripheral surface 142 of the optic 12 portion 102 or intermittently rests against the outer peripheral surface 142 of the optic portion 13 102.
14 [0225] In some embodiments, for example, as shown in Fig. 6, the entire expandable protuberance 600 can be positioned below (or above) a halfway line or haptic midline 610. The 16 halfway line or haptic midline 610 can bisect the anterior-to-posterior height of the haptic 104 17 In these embodiments, no part of the expandable protuberance 600, in an unexpanded state, 18 can extend beyond the haptic midline 610. An anterior-to-posterior height of the expandable 19 protuberance 600 can be less than the anterior-to-posterior height of the radially inner wall 602.
21 [0226] In some embodiments, the expandable protuberance 600 can be adhered to the radially 22 inner portion 146 (e.g., the radially inner wall 602) of the haptic 104 by being cured into place.
23 For example, the expandable protuberance 600 can be adhered to a cavity, furrow, or groove 24 formed along the radially outermost portion 606 of the radially inner wall 602. In these instances, the expandable protuberance 600 can take up or occupy less than half the anterior-26 to-posterior height of the radially inner wall 602.
27 [0227] In further embodiments, the expandable protuberance 600 can refer to part of the 28 radially inner portion 146 (e.g., part of the radially inner wall 602) made of the composite 29 material 200. For example, the expandable protuberance 600 can refer to a part of the radially outermost portion 606 of the radially inner wall 602 made of the composite material 200.
1 [0228] Although Fig. 6 illustrates the cross-sectional profile of the expandable protuberance 2 600 as having primarily straight edges and corners, it is contemplated by this disclosure and it 3 should be understood by one of ordinary skill in the art that the cross-sectional profile of the 4 expandable protuberance 600 can also have rounded or curved edges and corners.
[0229] Fig. 6 also illustrate that an external energy 302 can be directed or otherwise applied to 6 the expandable protuberance 600 to induce a shape change in the expandable protuberance 600 7 (e.g., enlarge the expandable protuberance 600) to affect an optical parameter of the adjustable 8 AIOL 100.
9 [0230] The external energy 302 can be the same external energy 302 as previously disclosed.
For example, when the external energy 302 is light energy, the energy absorbing constituents 11 204 can absorb or otherwise capture the light energy and convert the light energy into thermal 12 energy to cause the expandable components 206 within the composite material 200 to expand.
13 [0231] As shown in Fig. 6, the external energy 302 can cause the expandable protuberance 600 14 to expand (as depicted by the enlarged protuberance 600 shown in broken lines). Expansion of the expandable protuberance 600 can cause the protuberance 600 to encroach, extend, or 16 otherwise grow into the fluid-filled haptic fluid chamber 120. This can cause fluid within the 17 haptic fluid chamber 120 to be displaced or pushed So the optic fluid chamber 110 (through 18 the plurality of fluid channels 122). Moreover, when the protuberance 600 expands and part of 19 the protuberance 600 encroaches, extends, or grows into the haptic fluid chamber 120, the fluid carrying capacity or the available volume of the haptic fluid chamber 120 can decrease.
21 [0232] As previously discussed, both the haptic fluid chamber(s) 120 and the optic fluid 22 chamber 110 can be filled with a fluid (e.g., silicone oil). Reducing the fluid carrying capacity 23 or the available volume of the haptic fluid chamber 120 can cause at least some of the fluid 24 within the haptic fluid chamber(s) 120 to flow from the haptic fluid chamber(s) 120 into the optic fluid chamber 120, and remain in the optic fluid chamber 120. Although fluid flow 26 between the haptic fluid chamber 120 and the optic fluid chamber 120 is shown in Fig. 6 using 27 the curved arrow depicted using broken-lines, it should be understood by one of ordinary skill 28 in the art that fluid flows from the haptic fluid chamber(s) 120 to the optic fluid chamber 120 29 via the plurality of fluid channels 122.
[0233] As previously discussed, the base power of the optic portion 102 can be configured to 31 change based on an internal fluid pressure within the fluid-filled optic fluid chamber 110. The 1 base power of the optic portion 102 can be configured to increase as fluid enters the optic fluid 2 chamber 110 from the haptic fluid chamber(s) 120.
3 [0234] The optic portion 102 can also be configured to change shape in response to fluid 4 entering the optic fluid chamber 110. In certain embodiments, the anterior element 106 of the optic portion 102 can be configured to change shape (e.g., increase its curvature) in response to 6 the fluid entering the optic fluid chamber 110. In other embodiments, the posterior element 7 108 of the optic portion 102 can be configured to change shape (e.g., increase its curvature) in 8 response to the fluid entering the optic fluid chamber 110. In further embodiments, both the 9 anterior element 106 and the posterior element 108 can be configured to change shape in response to the fluid entering the optic fluid chamber 110. The base power of the optic portion 11 102 can be configured to increase in response to the shape change(s) undertaken by the 12 anterior element 106, the posterior element 108, or a combination thereof.
13 [0235] In some embodiments, bursts or pulses of external energy 302 (e.g., light energy) 14 directed at the expandable protuberance 600 can result in an increase in the base power of the adjustable AIOL 100 by between about +0.10 D and about +0.20 D (e.g., about +0.125 D). For 16 example, pulses of green laser light directed at the expandable protuberance 600 can result in 17 an increase in the base power of the adjustable AIOL 100 by between about +0.10 D and about 18 +0.20 D (e.g., about +0.125 D). In some embodiments, the base power of the adjustable AIOL
19 100 can increase between about +1.0 D to about +5.0 D (e.g., about +2.0 D) in total in response to bursts or pulses of the external energy 302 directed at the expandable protuberance 21 600.
22 [0236] Figs. 7A and 7B illustrate top and sectional views, respectively, of another embodiment 23 of the adjustable AIOL 100 comprising both an expandable spreader 500 and an expandable 24 protuberance 600 making up at least part of each of the haptics 104. For example, as shown in Fig. 7A, a first haptic portion made of the expandable spreader 500 can be positioned or 26 adhered to one part of the haptic chamber wall and a second haptic portion made of the 27 expandable protuberance 600 can be positioned or adhered to another part of the same "'optic 28 chamber wall.
29 [0237] In some embodiments, the first haptic portion (e.g., the expandable spreader 500) can be made in part of a first composite material, or a first type of the composite material 200 31 shown in Fig. 2A, and the second haptic portion (e.g., the expandable protuberance 600) can 1 be made in part of a second composite material, or a second type of the composite material 200 2 shown in Fig. 2A.
3 [0238] In some embodiments, the first composite material can be made in part of a first energy 4 absorbing constituent (e.g., a first type of the energy absorbing constituent 204 shown in Fig.
2A) and the second composite material can be made in part of a second energy absorbing 6 constituent (e.g., a second type of the energy absorbing constituent 204 shown in Fig. 2A). For 7 example, the first composite material can be made in part of Disperse Red 1 dye and the 8 second composite material can be made in part of graphitized carbon black. The first energy 9 absorbing constituent can have or exhibit a first color (e.g., the Disperse Red 1 dye can have or exhibit a red color) and the second energy absorbing constituent can have or exhibit a second 11 color (e.g., the graphitized carbon black can have or exhibit a black color) different from the 12 first color. Also, as another example, the first energy absorbing constituent can be an azo dye 13 having a first color (e.g., Disperse Red 1 dye) and the second energy absorbing constituent can 14 be another azo dye having a second color (e.g., Disperse Orange 1 dye).
This difference in color can allow a clinician or another medical professional to visually differentiate between the 16 two haptic portions.
17 [0239] In certain embodiments, the first composite material made in part of the first energy 18 absorbing constituent can expand in response to a first type of external energy (e.g., light 19 energy between 520 nm to 540 nm) directed at the first composite material and the second composite material made in part of the second energy absorbing constituent can expand in 21 response to a second type of external energy (e.g., light energy between 600 nm and 650 nm) 22 directed at the second energy absorbing constituent. In these and other embodiments, the first 23 energy absorbing constituent can have or exhibit a first color (e.g., red color) and the second 24 energy absorbing constituent can have or exhibit a second color (e.g., an orange or blue color) different from the first color.
26 [0240] In other embodiments, the first composite material and the second composite material 27 can be made in part of the same energy absorbing constituents but comprise different amounts 28 or weight percentages of such constituents. In other embodiments, the first composite material 29 and the second composite material can be made in part of the same energy absorbing constituents but comprise different amounts or weight percentages of expandable components 31 206.
1 [0241] As shown in Fig. 7A, the first haptic portion made in part of the first composite 2 material can be positioned or located radially offset from the second haptic portion made in 3 part of the second composite material. For example, the expandable spreader 500 can be 4 positioned radially offset from the expandable protuberance 600 on each of the haptics 104.
More specifically, a radially innermost portion of the haptic 104 can be made in part of the 6 expandable spreader 500 and an adjoining portion of the haptic radially outward from the 7 expandable spreader 500 can be made in part of the expandable protuberance 600.
8 [0242] Also, as shown in Fig. 7A, the expandable spreader 500 can extend along part of a 9 length of the haptic 104. Moreover, the expandable protuberance 600 can also extend along part of the length of the haptic 104.
11 [0243] Fig. 7B illustrates that the same radially inner wall 602 of the haptic 104 can comprise 12 both an expandable spreader 500 and an expandable protuberance 600. In the embodiment 13 shown in Fig. 7B, the expandable spreader 500 can be made in part of a first composite 14 material (e.g., a composite material 200 comprising a first energy absorbing colorant) and the expandable protuberance 600 can be made in part of a second composite material (e.g., a 16 composite material 200 comprising a second energy absorbing colorant).
The difference in the 17 color of the energy absorbing colorants can allow a clinician or another medical professional to 18 more easily distinguish the expandable spreader 500 and the expandable protuberance 600. In 19 other embodiments (for example, as depicted in Fig. 9B), the expandable spreader 500 and the expandable protuberance 600 can be made of the same composite material 200.
21 [0244] The expandable spreader 500 can be positioned within a channel 502 or opening 22 defined within the radially inner wall 602. The channel 502 or opening can be in fluid 23 communication with the haptic fluid chamber 120.
24 [0245] In some embodiments, the expandable spreader 500 can occupy a radially innermost portion 700 of the radially inner wall 602 of the haptic 104. In these embodiments, the 26 expandable spreader 500 can also occupy or be disposed at a radially innermost end of the 27 channel 502. In further embodiments, the expander spreader 500 can refer to part of a haptic 28 chamber wall of the haptic 104 made of the composite material 200. For example, in these 29 embodiments, the expander spread 500 can refer to part of the radially innermost portion 700 of the radially inner wall 602 of the haptic 104 made of the composite material 200.
1 [0246] As shown in Fig. 7B, a void space 608 or gap can separate the radially innermost 2 portion 700 of the radially inner wall 602 of the haptic 104 from the outer peripheral surface 3 142 of the optic portion 102. This can allow the expandable spreader 500 to expand without 4 impinging on or pushing up against the outer peripheral surface 142 of the optic portion 102.
[0247] As further shown in Fig. 7B, the expandable protuberance 600 can be positioned or 6 otherwise disposed or affixed along a radially outermost portion 606 of the radially inner wall 7 602 of the haptic 104. In certain embodiments, the expandable protuberance 600 can refer to 8 part of the haptic chamber wall made of the composite material 200. For example, the 9 expandable protuberance 600 can refer to part of the radially outermost portion 606 of the radially inner wall 602 of the haptic 104 made of the composite material 200.
11 [0248] External energy 302 directed or otherwise applied to the expander spreader 500 12 positioned along the haptic chamber wall (e.g., positioned along the radially innermost portion 13 700 of the radially inner wall 602 of the haptic 104) can cause the expandable spreader 500 to 14 expand. Expansion of the expandable spreader 500 can cause the spreader 500 to push against the channel walls 506 of the channel 502 and enlarge at least one of the channel 502 and the 16 haptic fluid chamber 120. This can cause the volume of the haptic fluid chamber(s) 120 to 17 increase. This can then draw fluid out of the optic fluid chamber 110 into the haptic fluid 18 chamber(s) 120 (via the fluid channels 122) and cause a decrease in the base power of the 19 adjustable AIOL 100 (e.g., a decrease between about -0.10 D and -0.20 D).
[0249] The same external energy 302 or another type of external energy 302 (e.g., light energy 21 of another wavelength) can also be directed or otherwise applied to the expandable 22 protuberance 600 positioned along the haptic chamber wall (e.g., positioned along the radially 23 outermost portion 606 of the radially inner wall 602 of the haptic 104).
The external energy 24 can cause the expandable protuberance 600 to expand. Expansion of the expandable spreader 500 can cause the protuberance 600 to encroach, extend, or otherwise grow into the fluid-filled 26 haptic fluid chamber 120. This can cause fluid within the haptic fluid chamber 120 to be 27 displaced or pushed into the optic fluid chamber 110 (through the plurality of fluid channels 28 122). Bursts or pulses of external energy 302 (e.g., light energy) directed at the expandable 29 protuberance 600 can result in an increase in base power of the adjustable AIOL 100 by between about +0.10 D and +0.20 D.
1 [0250] Fig. 8 illustrates a top plan view of another embodiment of the adjustable AIOL 100 2 comprising both expandable spreaders 500 and expandable protuberances 600 implemented as 3 discrete components 800 along the haptics 104. In alternative embodiments, at least one of the 4 expandable spreaders 500 and the expandable protuberances 600 can be replaced with expandable spacers 300 (see Figs. 3A and 3B).
6 [0251] In some embodiments, the expandable spreaders 500 can occupy or be positioned along 7 a radially innermost portion 700 (see, Fig. 7B) of the radially inner wall 602 of the haptic(s) 8 104. The expandable protuberances 600 can occupy or be positioned along a radially 9 outermost portion 606 (see, Fig. 6) of the radially inner wall 602 of the haptic(s) 104.
[0252] At least one of the expandable spreaders 500 and the expandable protuberances 600 11 can be implemented or configured as discrete components 800 visually perceptible to a 12 clinician or another medical professional responsible for adjusting the adjustable AIOL 100 13 when the adjustable AIOL 100 is implanted within an eye of a patient.
14 [0253] The discrete components 800 can refer to a shape or configuration of the expandable spreaders 500, the expandable protuberances 600, or a combination thereof. In some 16 embodiments, the discrete components 800 can have a circular profile when viewed from the 17 top down or when viewed in an anterior to posterior direction. In these embodiments, each of 18 the discrete components 800 can be shaped substantially as a cylinder.
In other embodiments 19 not shown in the figures, the discrete components 800 can have an oval profile, a rectangular profile, a triangular profile, a diamond or rhombus profile, a star profile, any other polygonal 21 profile, or a combination thereof when viewed from the top down or when viewed in an 22 anterior to posterior direction. The discrete components 800 can be spaced close apart or each 23 of the discrete components 800 can be separated from one another by portions of the haptic 24 material.
[0254] Moreover, as shown in Fig. 8, a portion or segment of one haptic 104 can comprise the 26 expandable spreaders 500 and another portion or segment of the same haptic 104 can comprise 27 the expandable protuberances 600. For example, a distal segment 802 of each of the haptics 28 104 (e.g., a segment 802 closer to the closed free end 138 of the haptics 104) can comprise the 29 expandable spreaders 500 and a proximal segment 804 of each of the haptics 104 (e.g., a segment 804 closer to the optic portion 102) can comprise the expandable protuberances 600.
31 As shown in Fig 8, the expandable protuberances, implemented as discrete components 800, 1 can be radially offset or radially separated from the expandable spreaders 500, also 2 implemented as discrete components 800.
3 [0255] Designing or otherwise configuring at least one of the expandable spreaders 500 and 4 the expandable protuberances 600 as discrete components 800 can allow a clinician or medical professional to fine tune the adjustment of the adjustable AIOL 100. For example, the clinician 6 or medical professional can direct the external energy 302 at one of the discrete components 7 800 to either increase the base power of the adjustable AIOL 100 (when the discrete 8 component 800 is an expandable protuberance 600) or decrease the base power of the 9 adjustable AIOL 100 (when the discrete component 800 is an expandable spreader 500) by a set amount. More specifically, in certain embodiments, the discrete components 800 can be 11 sized, shaped, or located to allow bursts or pulses of the external energy 302 applied to each of 12 the discrete components 800 to adjust an optical parameter (e.g., a base power) of the 13 adjustable AIOL 100 by a predetermined or preset amount. For example, bursts or pulses of 14 the external energy 302 applied to or directed at each of the discrete components 800 can cause a change in the base power by about 0.10 D and 0.20 D (e.g., about 0.125 D).
16 [0256] Moreover, in this example, the clinician or medical professional can also direct further 17 bursts or pulses of the external energy 302 at the same discrete component 800 to further 18 increase or decrease the base power of the adjustable AIOL 100 or direct further bursts or 19 pulses of the external energy 302 at a different discrete component 800 to undo or negate a previous adjustment (for example, to decrease the base power after an increase of the base 21 power has been induced).
22 [0257] Although Fig. 8 illustrates the haptic(s) 104 comprising both the expandable spreaders 23 500 and the expandable protuberances 600 (configured as discrete components 800), it is 24 contemplated by this disclosure and it should be understood by one of ordinary skill in the art that each of the haptics 104 can also comprise only the expandable spreaders 500 or only the 26 expandable protuberances 600 as discrete components 800.
27 [0258] As shown in Figs. 7A, 7B, and 8, the adjustable AIOL 100 can be configured such that 28 a base power of the adjustable AIOL 100 can be adjusted in a first manner (e.g., increasing the 29 base power) by directing or otherwise applying an external energy 302 at a first portion of the haptic 104 made in part of the composite material 200. Moreover, the base power of the 31 adjustable AIOL 100 can be adjusted in a second manner (e.g., decreasing the base power) by 1 directing or otherwise applying additional bursts or pulses of the external energy 302 at a 2 second portion of the same or different haptic 104 made in part of the composite material 200.
3 In some embodiments, the composite material 200 used to make the first portion of the haptic 4 104 can be or exhibit a different color than the composite material 200 used to make the second portion of the haptic 104 as a result of differences in the energy absorbing constituents 6 204 making up the composite materials 200.
7 [0259] Fig. 9A illustrates a top plan view of another embodiment of the adjustable AIOL 100 8 comprising both expandable spreaders 500 and expandable protuberances 600 arranged in a 9 visually perceptible pattern 900. The visually perceptible pattern 900 can allow a clinician or medical professional responsible for post-operatively adjusting the adjustable AIOL 100 to 11 distinguish between the expandable spreaders 500 and the expandable protuberances 600, 12 especially when the expandable spreaders 500 and the expandable protuberances 600 are made 13 from the same composite material 200 having the same color (as shown in Fig. 9A). This can 14 allow the clinician or medical professional to more easily determine where to direct or apply the external energy 302 on the adjustable AIOL 100 in order to adjust an optical parameter of 16 the adjustable AIOL WO.
17 [0260] As shown in Fig. 9A-9C, the visually perceptible pattern 900 can include both a 18 continuous curved segment of the expandable protuberance 600 and spaced-apart branches or 19 fmger-shaped segments of the expandable spreaders 500 extending radially inward from the continuous curved segment. Fig. 9A also illustrates that the branches or finger-shaped 21 segments of the expandable protuberance 600 can be separated from one another by portions 22 of haptic material 902. The haptic material 902 can be the same haptic material used to 23 construct the remainder of the haptic(s) 104_ For example, the visually perceptible pattern 900 24 can be a comb-shaped pattern. In other embodiments, the visually perceptible pattern 900 can be a wave pattern, a chained-triangular pattern, a zig-zag pattern, or a combination thereof.
26 [0261] For example, a clinician or another medical professional can direct or otherwise apply 27 the external energy 302 at the spaced-apart branches or finger-shaped segments to expand the 28 expandable spreaders 500 in order to decrease the base power of the adjustable AIOL 100. The 29 clinician or medical professional can also direct or otherwise apply the external energy 302 at the expandable protuberance 600 shaped as the curved portion positioned radially outward of 1 the spaced-apart branches or finger-shaped segments to expand the expandable protuberance 2 600 in order to increase the base power of the adjustable AIOL 100.
3 [0262] Fig. 9B illustrates a sectional view of the embodiment of the adjustable AIOL 100 4 shown in Fig. 9A taken along cross-section A-A. As shown in Fig. 9B, this section of the haptic 104 can comprise both the expandable spreader 500 and the expandable protuberance 6 600 adhered, formed, or otherwise positioned along the radially inner wall 602. The 7 expandable spreaders 500 can be positioned along the radially innermost portion 700 of the 8 radially inner wall 602 or at a radially innermost end of a channel 502 defined along the 9 radially inner wall 602. The expandable protuberance 600 can be positioned along a radially outermost portion 606 of the radially inner wall 602 of the haptic 104. The expandable 11 protuberance 600 can be positioned underneath or further posterior of the expandable spreader 12 500. Moreover, the adjustable AIOL 100 can be configured such that a void space 608 or gap 13 separates the radially inner wall 602 of the haptic 104 from the outer peripheral surface 142 of 14 the optic portion 102 such that expansion of the expandable spreader 500 does not cause any part of the haptic 104 to substantially impinge on or push up against the outer peripheral 16 surface 142 of the optic portion 102 (thereby preventing the haptic(s) 104 from being pushed 17 against the sides of the capsular bag 304, which can cause deformation of the haptic(s) 104 and 18 affect the volume of the haptic fluid chamber(s) 120).
19 [0263] Fig. 9C illustrates a sectional view of the embodiment of the adjustable AIOL 100 shown in Fig. 9A taken along cross-section B-B. As shown in Fig. 9C, this section of the 21 haptic 104 can comprise only the expandable protuberance 600 adhered, formed, or otherwise 22 positioned along the radially inner wall 602. The expandable protuberance 600 can be 23 positioned along a radially outermost portion 606 of the radially inner wall 602 of the haptic 24 104. The remainder of the radially inner wall 602 can be made of the same haptic material 902 used to construct the rest of the haptic 104.
26 [0264] The visually perceptible pattern 900 can allow a clinician or medical professional to 27 more easily determine where to direct or apply the external energy 302 on the adjustable AIOL
28 100 in order to adjust an optical parameter of the adjustable AIOL 100.
This can be useful 29 when both the expandable spreaders 500 and the expandable protuberances 600 are made of the same composite material 200 having or exhibiting the same color. The clinician or medical 31 professional can direct or otherwise apply the external energy 302 exclusively at the 1 expandable protuberance 600 shaped as the curved portion to expand the expandable 2 protuberance 600 in order to increase the base power of the adjustable AIOL 100. The 3 clinician or medical professional can also direct or otherwise apply the external energy 302 4 exclusively at the branches or finger-shaped portion to expand the expandable spreaders 500 in order to decrease the base power of the adjustable AIOL 100.
6 [0265] One technical problem faced by the applicants is how to integrate the composite 7 material with the rest of the adjustable AIOL without interfering with the optical quality of the 8 lens. One solution discovered by the applicants and disclosed herein is to position or embed 9 the composite material within or along the haptic chamber walls. More specifically, the solution discovered by the applicants is to position or embed the composite material along or 11 within the radially inner wall of the haptic(s).
12 [0266] Fig. 10 illustrates a sectional view of an optic portion 102 of another embodiment of 13 the adjustable AIOL 100 comprising an adhesive layer 1000 made in part of the composite 14 material 200. In some embodiments, the adhesive layer 1000 can comprise the composite material 200 integrated or mixed with the adhesives 148 previously discussed.
In other 16 embodiments, the composite material 200 can be positioned or sandwiched in between layers 17 of the adhesive 148.
18 [0267] The adhesive layer 1000 can be positioned or disposed along the peripheral edge 150 19 of the posterior element 108 (i.e., the top of the raised inner surface 132). Although Fig. 10 illustrates the adhesive layer 1000 as being located along opposing sides of the optic portion 21 102, it should be understood by one of ordinary skill in the art that the adhesive layer 1000 22 extends circumferentially around the entire periphery of the optic portion 102. The adhesive 23 layer 1000 can also be referred to as rotationally symmetric.
24 [0268] In some embodiments, the base power of the adjustable AIOL 100 can be configured to decrease in response to an external energy 302 directed or otherwise applied at the adhesive 26 layer 1000. The adhesive layer 10000 can be configured to expand in response to the external 27 energy 302 directed at the adhesive layer 1000. The external energy 302 can be directed at the 28 entire adhesive layer 1000 surrounding the periphery of the optic portion 102.
29 [0269] Expansion of the adhesive layer 1000 can raise the anterior element 106 and increase the volume of the optic fluid chamber 110. This can cause the anterior element 106 to flatten 31 slightly as the internal fluid pressure within the fluid-filled optic fluid chamber 110 decreases.
1 [0270] In some embodiments, bursts or pulses of external energy 302 (e.g., light energy) 2 directed at the adhesive layer 1000 can result in a decrease in base power of the adjustable 3 AIOL 100 by between about -0.10 D and -0.20 D (e.g., about -0.125 D). For example, pulses 4 of green laser light directed at the adhesive layer 1000 can result in a decrease in the base power of the adjustable AIOL 100 by between about -0.10 D and -0.20 D (e.g., about -0.125 6 D). In some embodiments, the base power of the adjustable AIOL 100 can decrease between 7 about -1.0 D to about -5.0 D (e.g., about -2.0 D) in total in response to bursts or pulses of the 8 external energy 302 directed at the adhesive layer 1000.
9 [0271] Fig. 11 illustrates a perspective view of another embodiment of the adjustable AIOL
100 comprising an adjustable anterior element 1100 having the composite material 200 located 11 or positioned along diametrically opposed peripheral portions of the anterior element 1100. As 12 shown in Fig. 11, the composite material 200 can be shaped or configured as a number of 13 discrete components 800 arranged on opposing peripheral edges of the anterior element 1100.
14 [0272] For example, the composite material 200 can be shaped or configured as a plurality of discrete components 800 lined up along a first peripheral edge 1102 and a second peripheral 16 edge 1104 of the anterior element 1100. The first peripheral edge 1102 can be located 17 diametrically opposed to or separated by about 180 degrees from the second peripheral edge 18 1104. In all such embodiments, the composite material 200 does not extend along the entire 19 circumference or surround the entire periphery of the anterior element 1100.
[0273] In some embodiments, the composite material 200 can be located or adhered in 21 between the anterior optical surface 112 and the anterior inner surface 114. In other 22 embodiments, the composite material 200 can extend out or protrude partly from the anterior 23 optical surface 112. The composite material 200 can be visually perceptible to a clinician or 24 another medical professional when the adjustable AIOL 100 is implanted within an eye of a patient. For example, the composite material 200 can be made in part of an energy absorbing 26 constituent 204 or colorant having or exhibiting a color (e.g., red-color or black-color) that is 27 visually perceptible to the clinician or another medical professional.
28 [0274] The clinician or another medical professional can direct or otherwise apply an external 29 energy 302 to the composite material 200 (for example, to all of the composite material 200 shaped or configured as discrete components 800 along the first peripheral edge 1102 and the 31 second peripheral edge 1104). The composite material 200 can expand in response to this 1 application of external energy 302. This expansion or swelling of the composite material 200 2 can cause the anterior optical surface 112 of the anterior element 1100 to flatten or exhibit a 3 flatter curvature along a rust meridian (referred to as a flat meridian 1106) of the anterior 4 element 1100. The flat meridian 1106 can be substantially perpendicular to another meridian (referred to as a steep meridian 1108) of the anterior element 1100 where the curvature of the 6 anterior element 1100 along this other meridian is substantially unaffected by the expansion of 7 the composite material 200. In this manner, a cylinder or cylindricity is induced on the anterior 8 optical surface 112 of the anterior element 1100. This change in the cylindricity of the anterior 9 element 1100 can persist or remain substantially permanent even after the external energy 302 is no longer directed or applied to the anterior element 1100.
11 [0275] More specifically, in response to the application of the external energy 302, the radius 12 of curvature of the anterior optical surface 112 measured along the flat meridian 1106 can be 13 greater than the radius of curvature of the anterior optical surface 112 measured along the 14 steep meridian 1108. Moreover, in response to the application of the external energy 302, a peripheral thickness of the anterior element 1100 along the flat meridian 1106 can be greater 16 than a peripheral thickness of the anterior element 1100 along the steep meridian 1108_ 17 [0276] In some embodiments, applying or directing the external energy 302 at the composite 18 material 200 can induce the anterior element 1100 to have a cylinder power between about 19 +0.50 D to about +5.0 D (e.g., about +1.50D or about +3.0 D). The cylinder power can be measured along the steep meridian 1108 of the anterior element 1100.
21 [0277] Although Fig. 11 illustrates an adjustable AIOL 100 comprising an adjustable anterior 22 element 1100 having the composite material 200, it is contemplated by this disclosure that the 23 adjustable AIOL 100 can also comprise an adjustable posterior element having the composite 24 material 200. For example, the composite material 200 can be located or positioned along diametrically opposed peripheral portions of the posterior element. The composite material 26 200 can be shaped or configured as a number of discrete components 800 arranged on 27 opposing peripheral edges of the posterior element.
28 [0278] In some embodiments, the composite material 200 can be located or adhered in 29 between the posterior optical surface 116 and the posterior inner surface 118 (see, for example, Figs. 1B and 1C). In other embodiments, the composite material 200 can extend out or 31 protrude partly from the posterior optical surface 116. The composite material 200 can be 1 visually perceptible to a clinician or another medical professional when the adjustable AIOL
2 100 is implanted within an eye of a patient.
3 [0279] The clinician or another medical professional can direct or otherwise apply an external 4 energy 302 to the composite material 200 making up part of the peripheral edges of the posterior element. The composite material 200 can expand in response to this application of 6 external energy 302. This expansion or swelling of the composite material 200 can cause the 7 posterior optical surface 116 to flatten or exhibit a flatter curvature along a flat meridian of the 8 posterior element. The flat meridian can be substantially perpendicular to a steep meridian of 9 the posterior element where the curvature of the posterior element along the steep meridian is substantially unaffected by the expansion of the composite material 200. In this manner, a 11 cylinder or cylindricity is induced on the posterior optical surface 116 of the posterior element.
12 This change in the cylindricity of the posterior element can persist or remain substantially 13 permanent even after the external energy 302 is no longer directed or applied to the posterior 14 element.
[0280] More specifically, in response to the application of the external energy 302, the radius 16 of curvature of the posterior optical surface 116 measured along the flat meridian can be 17 greater than the radius of curvature of the posterior optical surface 116 measured along the 18 steep meridian. Moreover, in response to the application of the external energy 302, a 19 peripheral thickness of the posterior element along the flat meridian can be greater than a peripheral thickness of the posterior element along the steep meridian.
21 [0281] In some embodiments, applying or directing the external energy 302 at the composite 22 material 200 can induce the posterior element to have a cylinder power between about +0.5 D
23 to about -1-5.0 D (e.g., about +1.5D or about +3.0 D). The cylinder power can be measured 24 along the steep meridian of the posterior element.
[0282] One technical problem faced by the applicants is how to induce cylindricity or cylinder 26 in an accommodating intraocular lens without interfering with the optical quality of the lens.
27 One solution discovered by the applicants and disclosed herein is to position or embed the 28 composite material along or within the peripheral edges of an optical element (e.g., the anterior 29 element, the posterior element, or a combination thereof). More specifically, the solution discovered by the applicants is to position or embed the composite material along or within 1 part of two diametrically opposed peripheral edges of at least one of the anterior element and 2 the posterior element.
3 [0283] Disclosed herein is an intraocular lens, comprising: an optic portion; a peripheral 4 portion coupled to the optic portion; wherein at least one of the optic portion and the peripheral portion is made in part of a composite material comprising an energy absorbing 6 constituent and a plurality of expandable components, and wherein a base power of the optic 7 portion is configured to change in response to an external energy directed at the composite 8 material.
9 [0284] The intraocular lens as disclosed herein, wherein the base power of the optic portion is configured to change in response to the external energy directed at the composite material 11 when the intraocular lens is implanted within an eye of a subject.
12 [0285] The intraocular lens as disclosed herein, wherein the expandable components are 13 expandable microspheres, wherein each of the expandable microspheres comprises a blowing 14 agent contained within a thermoplastic shell.
[0286] The intraocular lens as disclosed herein, wherein the blowing agent is a branched-chain 16 hydrocarbon.
17 [0287] The intraocular lens as disclosed herein, wherein the branched-chain hydrocarbon is 18 isopentane.
19 [0288] The intraocular lens as disclosed herein, wherein a thickness of the thermoplastic shell is configured to change in response to the external energy directed at the composite material.
21 [0289] The intraocular lens as disclosed herein, wherein the thermoplastic shell is made in part 22 of an acrylonitrile copolymer.
23 [0290] The intraocular lens as disclosed herein, wherein a diameter of at least one of the 24 expandable micmspheres is configured to increase between about 2X to about 4X in response to the external energy directed at the composite material.
26 [0291] The intraocular lens as disclosed herein, wherein a volume of at least one of the 27 expandable components is configured to expand between about 10X to 50X
in response to the 28 external energy directed at the composite material.
29 [0292] The intraocular lens as disclosed herein, wherein the expandable components comprise between about 5% to about 15% by weight of the composite material.
1 [0293] The intraocular lens as disclosed herein, wherein the expandable components comprise 2 about 10% by weight of the composite material.
3 [0294] The intraocular lens as disclosed herein wherein the energy absorbing constituent is an 4 energy absorbing colorant.
[0295] The intraocular lens as disclosed herein, wherein a color of the energy absorbing 6 colorant is visually perceptible to a clinician when the intraocular lens is implanted within an 7 eye.
8 [0296] The intraocular lens as disclosed herein, wherein the energy absorbing colorant is a 9 dye.
[0297] The intraocular lens as disclosed herein, wherein the dye is an azo dye.
11 [0298] The intraocular lens as disclosed herein, wherein the dye is a Disperse Red 1 dye.
12 [0299] The intraocular lens as disclosed herein, wherein the energy absorbing colorant is a 13 pigment.
14 [0300] The intraocular lens as disclosed herein, wherein the pigment is graphitized carbon black.
16 [0.301] The intraocular lens as disclosed herein, wherein the at least one of the optic portion 17 and the peripheral portion is made in part of a first composite material and a second composite 18 material, wherein the first composite material comprises a first energy absorbing colorant and 19 the second composite material comprises a second energy absorbing colorant, wherein a color of the first energy absorbing colorant is different from a color of the second energy absorbing 21 colorant.
22 [0302] The intraocular lens as disclosed herein, wherein the energy absorbing constituent 23 comprises between about 0.025% to about 1.00% by weight of the composite material.
24 [0303] The intraocular lens as disclosed herein, wherein at least one of the optic portion and the peripheral portion is made in part of a cross-linked copolymer comprising a copolymer 26 blend, and wherein the composite material is made in part of the copolymer blend.
27 [0304] The intraocular lens as disclosed herein, wherein the copolymer blend comprises an 28 allcyl acrylate, a fluoro-alkyl acrylate, and a phenyl-alkyl acrylate.
29 [0305] The intraocular lens as disclosed herein, wherein the composite material further comprises at least one of reactive acrylic monomer diluents, a photoinitiator, and a thermal 31 initiator.
1 [0306] The intraocular lens as disclosed herein, wherein the composite material adheres to the 2 cross-linked copolymer at a location within the at least one of the optic portion and the 3 peripheral portion, and wherein the composite material remains substantially fixed at the 4 location.
[0307] The intraocular lens as disclosed herein, wherein the base power of the optic portion is 6 configured to change between about 0.05 D to about 0.5 D in response to pulses of the 7 external energy directed at the composite material.
8 [0308] The intraocular lens as disclosed herein, wherein the base power of the optic portion is 9 configured to change by up to -5.0D in total.
[0309] The intraocular lens as disclosed herein, wherein the external energy is light energy.
11 [0310] The intraocular lens as disclosed herein, wherein the light energy is a laser light.
12 [0311] The intraocular lens as disclosed herein, wherein the laser light has a wavelength 13 between about 488 nnt to about 650 nm.
14 [0312] The intraocular lens as disclosed herein, wherein the laser light is a green laser light.
[0313] The intraocular lens as disclosed herein, wherein the green laser light has a wavelength 16 of about 532 um.
17 [0314] The intraocular lens as disclosed herein, wherein the optic portion is made in part of 18 the composite material, and wherein the base power is configured to change in response to the 19 external energy directed at the optic portion.
[0315] The intraocular lens as disclosed herein, wherein the peripheral portion is made in part 21 of the composite material, and wherein the base power of the optic portion is configured to 22 change in response to the external energy directed at the peripheral portion.
23 [0316] The intraocular lens as disclosed herein, wherein the optic portion is made in part of 24 the composite material, and wherein a cylindricity of an optical surface of the optic portion is configured to change in response to the external energy directed at the optic portion.
26 [0317] The intraocular lens as disclosed herein, wherein the change in the cylindricity of the 27 optic portion is a persistent change.
28 [0318] The intraocular lens as disclosed herein, wherein the change in the base power is a 29 persistent change.
1 [0319] The intraocular lens as disclosed herein, wherein the optic portion comprises an 2 anterior element having an anterior optical surface and a posterior element having a posterior 3 optical surface.
4 [0320] The intraocular lens as disclosed herein, wherein the composite material is located along a first peripheral edge of the anterior element and along a second peripheral edge of the 6 anterior element diametrically opposed to the first peripheral edge, and wherein the 7 cylindricity of the anterior optical surface is configured to change in response to the external 8 energy directed at the first peripheral edge and the second peripheral edge.
9 [0321] The intraocular lens as disclosed herein, wherein the composite material is located along a first peripheral edge of the posterior element and along a second peripheral edge of the 11 posterior element diametrically opposed to the first peripheral edge, and wherein the 12 cylindricity of the posterior optical surface is configured to change in response to the external 13 energy directed at the first peripheral edge and the second peripheral edge.
14 [0322] The intraocular lens as disclosed herein, wherein the optic portion comprises an anterior element, a posterior element, and a fluid-filled optic chamber defined therebetween, 16 and wherein the anterior element is bonded or adhered circumferentially to the posterior 17 element by an adhesive layer and wherein the adhesive layer comprises the composite 18 material.
19 [0323] The intraocular lens as disclosed herein, wherein the base power is configured to decrease in response to an expansion of the adhesive layer as a result of the external energy 21 directed at the composite material within the adhesive layer.
22 [0324] The intraocular lens as disclosed herein, wherein the optic portion comprises a fluid-23 filled optic chamber and the peripheral portion comprises at least one haptic comprising a 24 fluid-filled haptic fluid chamber in fluid communication with the optic chamber.
[0325] The intraocular lens as disclosed herein, wherein the base power is configured to 26 change in response to fluid displacement between the optic chamber and the haptic fluid 27 chamber as a result of the external energy directed at the composite material.
28 [0326] The intraocular lens as disclosed herein, wherein the base power is configured to 29 change in response to a change in a volume of the haptic fluid chamber as a result of the external energy directed at the composite material.
1 [0327] The intraocular lens as disclosed herein, wherein the base power is configured to 2 change in response to an interaction between the haptic and a capsular environment 3 surrounding the intraocular lens when the intraocular lens is implanted within an eye.
4 [0328] The intraocular lens as disclosed herein, wherein the composite material is configured as a spacer extending radially from a haptic chamber wall, wherein the spacer is configured to 6 expand in response to the external energy directed at the spacer, and wherein expansion of the 7 spacer decreases a volume of the haptic fluid chamber by pushing the haptic against the 8 capsular environment.
9 [0329] The intraocular lens as disclosed herein, wherein the composite material is located partly within a haptic chamber wall surrounding the haptic fluid chamber.
11 [0330] The intraocular lens as disclosed herein, wherein the composite material is located at 12 least partially within a channel formed along a radially inner wall of the haptic, wherein a 13 volume of the haptic fluid chamber is configured to expand in response to the external energy 14 directed at the composite material.
[0331] The intraocular lens as disclosed herein, wherein the composite material is located at 16 least partly along a radially outermost portion of a radially inner wall of the haptic, wherein a 17 volume of the haptic fluid chamber is configured to decrease in response to the external energy 18 directed at the composite material.
19 [0332] The intraocular lens as disclosed herein, wherein the composite material is configured to expand into the haptic fluid chamber in response to the external energy directed at the 21 composite material.
22 [0333] The intraocular lens as disclosed herein, wherein the energy absorbing constituent is 23 configured to transfer thermal energy to the plurality of expandable components in response to 24 the external energy directed at the composite material.
[0334] Also disclosed herein is an accommodating intraocular lens, comprising:
an optic 26 portion; and a haptic coupled to the optic portion, wherein the haptic comprises a first haptic 27 portion and a second haptic portion, wherein the first haptic portion is made in part of a 28 composite material comprising an energy absorbing constituent and a plurality of expandable 29 components, wherein the second haptic portion is made in part of the composite material, wherein a base power of the optic portion is configured to increase in response to an external 1 energy directed at the first haptic portion, and wherein the base power of the optic portion is 2 configured to decrease in response to the external energy directed at the second haptic portion.
3 [0335] The accommodating intraocular lens as disclosed herein, wherein the optic portion 4 comprises a fluid-filled optic fluid chamber and the haptic comprises a fluid-filled haptic fluid chamber in fluid communication with the optic fluid chamber.
6 [0336] The accommodating intraocular lens as disclosed herein, wherein the base power of the 7 optic portion is configured to increase in response to the external energy directed at the first 8 haptic portion as a result of fluid flowing from the haptic fluid chamber to the optic fluid 9 chamber.
[0337] The accommodating intraocular lens as disclosed herein, wherein the base power of the 11 optic portion is configured to decrease in response to the external energy directed at the second 12 haptic portion as a result of fluid flowing from the optic fluid chamber to the haptic fluid 13 chamber.
14 [0338] The accommodating intraocular lens as disclosed herein, wherein at least one of the first haptic portion and the second haptic portion is located partly within a haptic chamber wall 16 surrounding the haptic fluid chamber.
17 [0339] The accommodating intraocular lens as disclosed herein, wherein the first haptic 18 portion is made in part of a first composite material, wherein the second haptic portion is made 19 in part of a second composite material, wherein the first composite material comprises a first energy absorbing constituent, wherein the second composite material comprises a second 21 energy absorbing constituent, and wherein a composition of the first energy absorbing 22 constituent is different from a composition of the second energy absorbing constituent.
23 [0340] The accommodating intraocular lens as disclosed herein, wherein the first haptic 24 portion is made in part of a first composite material, wherein the second haptic portion is made in part of a second composite material, wherein the first composite material comprises a first 26 energy absorbing constituent, wherein the second composite material comprises a second 27 energy absorbing constituent, and wherein a composition of the first energy absorbing 28 constituent is the same as a composition of the second energy absorbing constituent.
29 [0341] The accommodating intraocular lens as disclosed herein, wherein the first energy absorbing constituent has a first color and wherein the second energy absorbing constituent has 31 a second color different from the first color.
1 [0342] The accommodating intraocular lens as disclosed herein, wherein the first haptic 2 portion is radially offset from the second haptic portion.
3 [0343] The accommodating intraocular lens as disclosed herein, wherein at least one of the 4 first haptic portion and the second haptic portion is oriented in a pattern such that a location of the at least one of the first haptic portion and the second haptic portion along the haptic is 6 visually perceptible to a clinician.
7 [0344] Also disclosed herein is a method of adjusting an accommodating intraocular lens, 8 comprising: adjusting a base power of the accommodating intraocular lens by directing an 9 external energy at a composite material within at least one of an optic portion and a peripheral portion of the accommodating intraocular lens, wherein the composite material comprises an 11 energy absorbing constituent and a plurality of expandable components.
12 [0345] The method as disclosed herein, further comprising adjusting the base power of the 13 accommodating intraocular lens when the accommodating intraocular lens is implanted within 14 an eye of a subject.
[0346] The method as disclosed herein, further comprising adjusting the cylindricity of an 16 optical surface of an optic portion the accommodating intraocular lens by directing an external 17 energy at the composite material arranged at diametrically opposed peripheral edges of the 18 optic portion.
19 [0347] The method as disclosed herein, further comprising directing the external energy at the composite material to energize the energy absorbing constituent to cause thermal energy to be 21 transferred to the plurality of expandable components.
22 [0348] The method as disclosed herein, wherein the plurality of expandable components are 23 expandable thermoplastic microspheres, wherein directing the external energy at the composite 24 material expands the thermoplastic microspheres.
[0349] The method as disclosed herein, wherein the external energy is light energy.
26 [0350] The method as disclosed herein, wherein the light energy is a laser light having a 27 wavelength between about 488 nm to about 650 nm.
28 [0351] The method as disclosed herein, further comprising adjusting the base power of the 29 optic portion between about 0.05 D to about - 0.5 D by directing pulses of the external energy at the composite material.
1 [0352] The method as disclosed herein, wherein the optic portion comprises a fluid-filled optic 2 chamber and the peripheral portion comprises at least one haptic comprising a fluid-filled 3 haptic fluid chamber in fluid communication with the optic chamber, wherein the method 4 further comprises directing the external energy at the composite material to displace fluid between the optic chamber and the haptic fluid chamber.
6 [0353] The method as disclosed herein, further comprising adjusting the base power of the 7 accommodating intraocular lens by directing the external energy at the composite material to 8 change a volume of the haptic fluid chamber.
9 [0354] The method as disclosed herein, further comprising adjusting the base power of the accommodating intraocular lens by directing the external energy at the composite material to 11 cause the peripheral portion to interact with a capsular environment surrounding the 12 accommodating intraocular lens when the accommodating intraocular lens is implanted within 13 an eye.
14 [0355] The method as disclosed herein, further comprising adjusting the base power of the accommodating intraocular lens by directing the external energy at the composite material to 16 change a volume of the optic fluid chamber.
17 [0356] The method as disclosed herein, wherein at least one of the optic portion and the 18 peripheral portion is made in part of a cross-linked copolymer comprising a copolymer blend, 19 and wherein the composite material is made in part of the copolymer blend.
[0357] A number of embodiments have been described. Nevertheless, it will be understood by 21 one of ordinary skill in the art that various changes and modifications can be made to this 22 disclosure without departing from the spirit and scope of the embodiments. Elements of 23 systems, devices, apparatus, and methods shown with any embodiment are exemplary for the 24 specific embodiment and can be used in combination or otherwise on other embodiments within this disclosure. For example, the steps of any methods depicted in the figures or 26 described in this disclosure do not require the particular order or sequential order shown or 27 described to achieve the desired results. In addition, other steps operations may be provided, or 28 steps or operations may be eliminated or omitted from the described methods or processes to 29 achieve the desired results. Moreover, any components or parts of any apparatus or systems described in this disclosure or depicted in the figures may be removed, eliminated, or omitted 31 to achieve the desired results. In addition, certain components or parts of the systems, devices, 1 or apparatus shown or described herein have been omitted for the sake of succinctness and 2 clarity.
3 [0358] Accordingly, other embodiments are within the scope of the following claims and the 4 specification and/or drawings may be regarded in an illustrative rather than a restrictive sense.
[0359] Each of the individual variations or embodiments described and illustrated herein has 6 discrete components and features which may be readily separated from or combined with the 7 features of any of the other variations or embodiments. Modifications may be made to adapt a 8 particular situation, material, composition of matter, process, process act(s) or step(s) to the 9 objective(s), spirit or scope of the present invention.
[0360] Methods recited herein may be carried out in any order of the recited events that is 11 logically possible, as well as the recited order of events. Moreover, additional steps or 12 operations may be provided or steps or operations may be eliminated to achieve the desired 13 result.
14 [0361] Furthermore, where a range of values is provided, every intervening value between the upper and lower limit of that range and any other stated or intervening value in that stated 16 range is encompassed within the invention. Also, any optional feature of the inventive 17 variations described may be set forth and claimed independently, or in combination with any 18 one or more of the features described herein. For example, a description of a range from 1 to 5 19 should be considered to have disclosed subranges such as from 1 to 3, from 1 to 4, from 2 to 4, from 2 to 5, from 3 to 5, etc. as well as individual numbers within that range, for example 1.5, 21 2.5, etc. and any whole or partial increments therebetween.
22 [0362] All existing subject matter mentioned herein (e.g., publications, patents, patent 23 applications) is incorporated by reference herein in its entirety except insofar as the subject 24 matter may conflict with that of the present invention (in which case what is present herein shall prevail). The referenced items are provided solely for their disclosure prior to the filing 26 date of the present application. Nothing herein is to be construed as an admission that the 27 present invention is not entitled to antedate such material by virtue of prior invention.
28 [0363] Reference to a singular item, includes the possibility that there are plural of the same 29 items present. More specifically, as used herein and in the appended claims, the singular forms "a," "an," "said" and "the" include plural referents unless the context clearly dictates 31 otherwise. It is further noted that the claims may be drafted to exclude any optional element.
1 As such, this statement is intended to serve as antecedent basis for use of such exclusive 2 terminology as "solely," "only" and the like in connection with the recitation of claim 3 elements, or use of a "negative" limitation. Unless defined otherwise, all technical and 4 scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.
6 [0364] Reference to the phrase "at least one of', when such phrase modifies a plurality of 7 items or components (or an enumerated list of items or components) means any combination 8 of one or more of those items or components. For example, the phrase "at least one of A, B, 9 and C" means: (i) A; (ii) B; (iii) C; (iv) A, B, and C; (v) A and B; (vi) B and C; or (vii) A and C
11 [0365] In understanding the scope of the present disclosure, the term "comprising" and its 12 derivatives, as used herein, are intended to be open-ended terms that specify the presence of 13 the stated features, elements, components, groups, integers, and/or steps, but do not exclude 14 the presence of other unstated features, elements, components, groups, integers and/or steps.
The foregoing also applies to words having similar meanings such as the terms, "including", 16 "having" and their derivatives. Also, the terms "part," "section,"
"portion," "member"
17 "element," or "component" when used in the singular can have the dual meaning of a single 18 part or a plurality of parts. As used herein, the following directional terms "forward, rearward, 19 above, downward, vertical, horizontal, below, transverse, laterally, and vertically" as well as any other similar directional terms refer to those positions of a device or piece of equipment or 21 those directions of the device or piece of equipment being translated or moved.
22 [0366] Finally, terms of degree such as "substantially", "about" and "approximately" as used 23 herein mean the specified value or the specified value and a reasonable amount of deviation 24 from the specified value (e.g., a deviation of up to - 0.1%, - 1%, -5%, or - 10%, as such variations are appropriate) such that the end result is not significantly or materially changed.
26 For example, "about 1.0 cm" can be interpreted to mean "1.0 cm" or between "0.9 cm and 1.1 27 cm." When terms of degree such as "about" or "approximately" are used to refer to numbers or 28 values that are part of a range, the term can be used to modify both the minimum and 29 maximum numbers or values.
[0367] This disclosure is not intended to be limited to the scope of the particular forms set 31 forth, but is intended to cover alternatives, modifications, and equivalents of the variations or 1 embodiments described herein. Further, the scope of the disclosure fully encompasses other 2 variations or embodiments that may become obvious to those skilled in the art in view of this 3 disclosure.
16 [0095] The base power of the optic portion 102 can be configured to increase as fluid enters 17 the fluid-filled optic fluid chamber 110 from the haptic fluid chamber(s) 120, as shown in Fig.
18 1B. The base power of the optic portion 102 can be configured to decrease as fluid exits or is 19 drawn out of the fluid-filled optic fluid chamber 110 into the haptic fluid chamber(s) 120, as shown in Fig. 1C.
21 [0096] It should be noted that although Fig. 1B illustrates the fluid entering the optic fluid 22 chamber 110 from the haptic fluid chambers 120 using the curved broken-line arrows, fluid 23 enters the optic fluid chamber 110 via the fluid channels 122 (including through the inner 24 apertures 128 and outer apertures 130) and haptic fluid ports 140. It should also be noted that although Fig. 1C illustrates the fluid exiting the optic fluid chamber 110 into the haptic fluid 26 chambers 120 using the curved broken-line arrows, fluid exits the optic fluid chamber 110 via 27 the fluid channels 122 (including through the inner apertures 128 and outer apertures 130) and 28 haptic fluid ports 140.
29 [0097] The optic portion 102 can be made in part of a deformable or flexible material. In some embodiments, the optic portion 102 can be made in part of a deformable or flexible polymeric 31 material. For example, the anterior element 106, the posterior element 108, or a combination 1 thereof can be made in part of a deformable or flexible polymeric material. The one or more 2 haptics 104 (e.g., the first haptic 104A, the second haptic 104B, or a combination thereof) can 3 be made in part of the same deformable or flexible material as the optic portion 102. In other 4 embodiments, the one or more haptics 104 can be made in part of different materials from the optic portion 102.
6 [0098] In some embodiments, the optic portion 102 can comprise or be made in part of a lens 7 body material. The lens body material can be made in part of a cross-linked copolymer 8 comprising a copolymer blend. The copolymer blend can comprise an alkyl acrylate or 9 methacrylate, a fluoro-alkyl (meth)acrylate, and a phenyl-alkyl acrylate.
It is contemplated by this disclosure and it should be understood by one of ordinary skill in the art that these types of 11 acrylic cross-linked copolymers can be generally copolymers of a plurality of acrylates, 12 methacrylates, or a combination thereof and the term "acrylate" as used herein can be 13 understood to mean acrylates, methacrylates, or a combination thereof interchangeably unless 14 otherwise specified. The cross-linked copolymer used to make the lens body material can comprise an alkyl acrylate in the amount of about 3% to 20% (wt%), a fluoro-alkyl acrylate in 16 the amount of about 10% to 35% (wt%), and a phenyl-alkyl acrylate in the amount of about 17 50% to 80% (wt%). In some embodiments, the cross-linked copolymer can comprise or be 18 made in part of an n-butyl acrylate as the alkyl acrylate, trifluoroethyl methacrylate as the 19 fluoro-alkyl acrylate, and phenylethyl acrylate as the phenyl-alkyl acrylate. More specifically, the cross-linked copolymer used to make the lens body material can comprise n-butyl acrylate 21 in the amount of about 3% to 20% (wt%) (e.g., between about 12% to 16%), trifluoroethyl 22 methacrylate in the amount of about 10% to 35% (wt%) (e.g., between about 17% to 21%), 23 and phenylethyl acrylate in the amount of about 50% to 80% (wt%) (e.g., between about 64%
24 to 67%).
[0099] The final composition of the cross-linked copolymer used to make the lens body 26 material can also comprise a cross-linker or cross-linking agent such as ethylene glycol 27 dimethacrylate (EGDMA). For example, the final composition of the cross-linked copolymer 28 used to make the lens body material can also comprise a cross-linker or cross-linking agent 29 (e.g., EGDMA) in the amount of about 1.0%. The final composition of the cross-linked copolymer used to make the lens body material can also comprise an initiator or initiating 31 agent (e.g., Perkadox 16) and a UV absorber.
1 [0100] The haptic(s) 104 can comprise or be made in part of a haptic material. The haptic 2 material can comprise or be made in part of a cross-linked copolymer comprising a copolymer 3 blend. The copolymer blend can comprise an alkyl acrylate, a fluoro-alkyl acrylate, and a 4 phenyl-alkyl acrylate. For example, the cross-linked copolymer used to make the haptic material can comprise an alkyl acrylate in the amount of about 10% to 25%
(wt%), a fluoro-6 alkyl acrylate in the amount of about 10% to 35% (wt%), and a phenyl-alkyl acrylate in the 7 amount of about 50% to 80% (wt%). In some embodiments, the cross-linked copolymer used 8 to make the haptic material can comprise n-butyl acrylate in the amount of about 10% to 25%
9 (wt%) (e.g., between about 19% to about 23%), trifluoroethyl methacrylate in the amount of about 10% to 35% (wt%) (e.g., between about 14% to about 18%), and phenylethyl acrylate in 11 the amount of about 50% to 80% (wt%) (e.g., between about 58% to about 62%). The final 12 composition of the cross-linked copolymer used to make the haptic material can also comprise 13 a cross-linker or cross-linking agent, such as EGDMA, in the amount of about 1.0%. The final 14 composition of the cross-linked copolymer used to make the haptic material can also comprise a number of photoinitiators or photoinitiating agents (e.g., camphorquinone, 1-phenyl-1,2-16 propanedione, and 2-ethylhexy1-4-(dimenthylamino)benzoate).
17 [0101] In some embodiments, the refractive index of the lens body material can be between 18 about 1.48 and about 1.53. In certain embodiments, the refractive index of the lens body 19 material can be between about 1.50 and about 1.53 (e.g., about 1.5178).
[0102] The optic portion 102 can be configured to deform, flex, or otherwise change shape 21 (see Figs. 1B and 1C) in response to fluid entering or exiting the optic fluid chamber 110. The 22 optic portion 102 can be configured to deform, flex, or otherwise change shape as a result of 23 the material composition (e.g., the polymeric composition) of the optic portion 102 discussed 24 heretofore. The haptic(s) 104 can also be configured to deform or otherwise change shape in response to interactions or engagement with the capsular bag of a patient when the adjustable 26 AIOL 100 is implanted within an eye of the patient. The haptic(s) 104 can be configured to 27 deform or otherwise change shape as a result of the material composition of the haptics 104.
28 [0103] In some embodiments, the anterior element 106 can be configured to deform, flex, or 29 otherwise change shape (e.g., change its curvature) in response to fluid entering or exiting the optic fluid chamber 110. In other embodiments, the posterior element 108 can be configured to 31 deform, flex, or otherwise change shape (e.g., change its curvature) in response to fluid 1 entering or exiting the optic fluid chamber 110. In further embodiments, both the anterior 2 element 106 and the posterior element 108 can be configured to deform, flex, or otherwise 3 change their shapes in response to fluid entering or exiting the optic fluid chamber 110.
4 [0104] In some embodiments, the fluid within the optic fluid chamber 110, the haptic fluid chamber(s) 120, or a combination thereof can be an oil. More specifically, in certain 6 embodiments, the fluid within the optic fluid chamber 110, the haptic fluid chamber(s) 120, or 7 a combination thereof can be a silicone oil or fluid. The fluid can flow between the optic fluid 8 chamber 110 and the haptic fluid chamber(s) 120 in response to a deformation, flexing, or 9 shape change undertaken by the haptic(s) 104, component(s) of the optic portion 102 (e.g., the anterior element 106, the posterior element 108, or a combination thereof), or a combination 11 thereof.
12 [0105] The fluid within the optic fluid chamber 110, the haptic fluid chamber(s) 120, or a 13 combination thereof can be a silicone oil or fluid comprising or made in part of a diphenyl 14 siloxane. In other embodiments, the silicone oil or fluid can comprise or be made in part of a ratio of two dimethyl siloxane units to one diphenyl siloxane unit. More specifically, in some 16 embodiments, the silicone oil or fluid can be a diphenyltetramethyl cyclotrisiloxane. In 17 additional embodiments, the silicone oil or fluid can comprise or be made in part of a diphenyl 18 siloxane and dimethyl siloxane copolymer.
19 [0106] The fluid (e.g., the silicone oil) can be index matched with the lens body material used to make the optic portion 102. When the fluid is index matched with the lens body material, 21 the entire optic portion 102 containing the fluid acts as a single lens.
For example, the fluid can 22 be selected so that it has a refractive index of between about 1.48 and 1.53 (or between about 23 1.50 and 1.53). In some embodiments, the fluid (e.g., the silicone oil) can have a 24 polydispersity index of between about 1.2 and 1.3. In other embodiments, the fluid (e.g., the silicone oil) can have a polydispersity index of between about 1.3 and 1.5. In other 26 embodiments, the fluid (e.g., the silicone oil) can have a polydispersity index of between about 27 1.1 and 1.2. Other example fluids are described in U.S. Patent Publication No. 2018/0153682, 28 which is herein incorporated by reference in its entirety.
29 [0107] The base power of the optic portion 102 can be configured to change in response to the shape change undertaken by the shape-changing components of the optic portion 102 (e.g., the 31 anterior element 106, the posterior element 108, or a combination thereof). The optic portion 1 102 can be configured to change shape in response to a physiologic muscle movement (e.g., 2 ciliary muscle movement) undertaken by a patient when the adjustable AIOL
100 is implanted 3 within a capsular bag of the eye of the patient and the adjustable AIOL
100 deforms or 4 changes shape in response to ciliary muscle related capsular bag reshaping.
[0108] The adjustable AIOL 100 can be implanted or introduced into a patient's capsular bag 6 after a native lens has been removed from the capsular bag. The patient's capsular bag is 7 connected to zonule fibers which are connected to the patient's ciliary muscles. The capsular 8 bag is elastic and ciliary muscle movements can reshape the capsular bag via the zonule fibers.
9 For example, when the ciliary muscles relax, the zonules are stretched.
This stretching pulls the capsular bag in the generally radially outward direction due to radially outward forces.
11 This pulling of the capsular bag causes the capsular bag to elongate, creating room within the 12 capsular bag. When the patient's native lens is present in the capsular bag, the native lens 13 normally becomes flatter (in the anterior-to-posterior direction), which reduces the power of 14 the lens, allowing for distance vision. In this configuration, the patient's native lens is said to be in a disacconunodated state or undergoing disaccommodation.
16 [0109] When the ciliary muscles contract, however, as occurs when the eye is attempting to 17 focus on near objects, the radially inner portion of the muscles move radially inward, causing 18 the zonules to slacken. The slack in the zonules allows the elastic capsular bag to contract and 19 exert radially inward forces on a lens within the capsular bag. When the patient's native lens is present in the capsular bag, the native lens normally becomes more curved (e.g., the anterior 21 part of the lens becomes more curved), which gives the lens more power, allowing the eye to 22 focus on near objects. In this configuration, the patient's native lens is said to be in an 23 accommodated state or undergoing accommodation_ 24 [0110] Therefore, any AIOLs implanted within the capsular bag should also possess mechanisms which allow for the base power of the AIOL to increase when the ciliary muscles 26 contract and allow for the base power of the AIOL to decrease when the ciliary muscles relax.
27 [0111] In the present case, when the adjustable AIOL 100 is implanted or otherwise 28 introduced into a patient's native capsular bag, the radially outer portions 144 of the haptics 29 104 of the adjustable AIOL 100 can directly engage with or be in physical contact with the portion of the capsular bag that is connected to the zonules or zonule fibers.
Therefore, the 31 radially outer portions 144 of the haptics 104 can be configured to respond to capsular bag 1 reshaping forces that are applied radially when the zonules relax and stretch as a result of 2 ciliary muscle movements.
3 [0112] When the ciliary muscles contract, the peripheral region of the elastic capsular bag 4 reshapes and applies radially inward forces on the radially outer portions 144 of the haptics 104 (for example, the elastic capsular bag applies radially inward forces on the radially outer 6 portion 144 of the first haptic 104A and on the radially outer portion 144 of the second haptic 7 10413). The radially outer portions 144 of the haptics 104 then deform or otherwise changes 8 shape and this deformation or shape change causes the volume of the haptic fluid chambers 9 120 to decrease. When the volume of the haptic fluid chambers 120 decreases, the fluid within the haptic fluid chambers 120 is moved or pushed into the optic fluid chamber 110 within the 11 optic portion 102. As discussed previously, fluid moves from the haptic fluid chamber 120 into 12 the optic fluid chamber 110 through fluid channels 122 (e.g., a pair of fluid channels 122) 13 formed within the optic portion 102.
14 [0113] The optic portion 102 (any of the anterior element 106, the posterior element 108, or a combination thereof) can change shape (increase its curvature) in response to the fluid entering 16 the optic fluid chamber 110 from the haptic fluid chambers 120. This increases the base power 17 or base spherical power of the adjustable AIOL 100 and allows a patient with the adjustable 18 AIOL 100 implanted within the eye of the patient to focus on near objects. The adjustable 19 AIOL 100 can also be considered to be in an accommodated state or have undergone accommodation.
21 [0114] When the ciliary muscles relax, the peripheral region of the elastic capsular bag is 22 stretched radially outward and the capsular bag elongates and more room is created within the 23 capsular bag. The radially outer portions 144 of the haptics 104 can be configured to respond 24 to this capsular bag reshaping by returning to its non-deformed or non-stressed configuration.
This causes the volume of the haptic fluid chambers 120 to increase or return to its non-26 deformed volume. This increase in the volume of the haptic fluid chambers 120 causes the 27 fluid within the optic fluid chamber 110 to be drawn out or otherwise flow out of the optic 28 fluid chamber 110 and back into the haptic fluid chambers 120. As discussed previously, fluid 29 moves out of the optic fluid chamber 110 into the haptic fluid chamber 120 through the same fluid channels 122 (e.g., a pair of fluid channels 122) formed within the optic portion 102.
1 [0115] As previously discussed, the optic portion 102 (any of the anterior element 106, the 2 posterior element 108, or a combination thereof) can change shape (decrease its curvature or 3 become flatter) in response to the fluid exiting the optic fluid chamber 110 and into the haptic 4 fluid chambers 120. This decreases the base power or base spherical power of the adjustable AIOL 100 and allows a patient with the adjustable AIOL 100 implanted within the eye of the 6 patient to focus on distant objects or provide for distance vision. The adjustable AIOL 100 can 7 also be considered to be in a disaccommodated state or have undergone disaccommodation.
8 [0116] As shown in Figs. 1B and IC, the radially inner portion 146 of the haptics 104 can be 9 designed to be thicker or bulkier (relative to the radially outer portion 144) to provide the haptics 104 with stiffness or resiliency in the anterior-to-posterior direction. This way, when 11 capsular bag forces are applied to the haptics 104 in the anterior-to-posterior direction, less 12 deformation occurs and less fluid movement occurs between the haptic fluid chambers 120 and 13 the optic fluid chamber 110 than when forces are applied in the radial direction. Since less 14 fluid movement occurs, less changes in the base power of the adjustable AIOL 100 occur when forces are applied to the adjustable AIOL 100 in the anterior-to-posterior direction. Thus, the 16 design and material properties of the haptics 104 and the optic portion 102 can allow the 17 adjustable AIOL 100 to maintain a high degree of sensitivity to radial forces applied to the 18 haptics 104 by capsular bag reshaping caused by ciliary muscle movements.
19 [0117] In some embodiments, the anterior element 106 can be configured such that the anterior optical surface 112 changes shape from a spherical surface configuration to an 21 aspherical surface configuration in response to fluid entering the optic fluid chamber 110. An 22 aspherical surface configuration can correct for high order aberrations such as spherical 23 aberration. The fluid can enter the optic fluid chamber 110 from one or more haptic fluid 24 chambers 120 coupled to the optic portion 102 in response to ciliary muscle movement.
[0118] The anterior optical surface 112 can be stressed into the aspherical surface 26 configuration as a center or central portion of the anterior element 106 flexes or bulges out 27 further than an outer periphery of the anterior element 106 which is held down by adhesives 28 148 or an adhesive layer (see Figs. 1B and 1C).
29 [0119] In other embodiments, the posterior element 108 can be configured such that the posterior optical surface 116 changes shape from a spherical surface configuration to an 31 aspherical surface configuration in response to fluid entering the optic fluid chamber 110.
1 [0120] The posterior optical surface 116 can be stressed into the aspherical surface 2 configuration as a center or central portion of the posterior element 108 flexes or bulges out 3 further than an outer periphery of the anterior element 106 which is held down by adhesives 4 148 or the adhesive layer.
[0121] The anterior element 106 can be attached or otherwise adhered to the posterior element 6 108 via adhesives 148 or an adhesive layer. The adhesive layer can be substantially annular-7 shaped. The adhesives 148 or adhesive layer can be positioned at a peripheral edge 150 (see 8 Fig. ID) of the optic portion 102 in between the anterior element 106 and the posterior element 9 108. For example, the adhesives 148 can be positioned on top of the raised inner surface 132 of the posterior element 108.
11 [0122] The adhesives 148 or adhesive layer can comprise or be made in part of a 12 biocompatible adhesive. The adhesives 148 or adhesive layer can comprise or be made in part 13 of a biocompatible polymeric adhesive.
14 [0123] The adhesives 148 or adhesive layer can comprise or be made in part of a cross-linkable polymer precursor formulation. The cross-linkable polymer precursor formulation can 16 comprise or be made in part of a copolymer blend, a hydmxyl-functional acrylic monomer, 17 and a photoinitiator.
18 [0124] The copolymer blend can comprise an alkyl acrylate (e.g., n-butyl acrylate in the 19 amount of about 41% to about 45% (wt%)), a fluoro-alkyl acrylate (e.g., trifluoroethyl methacrylate in the amount of about 20% to about 24% (wt%)), and a phenyl-alkyl acry late 21 (phenylethyl acrylate in the amount of about 28% to about 32% (wt%)).
The hydroxyl-22 functional acrylic monomer can be 2-hydroxyethyl acrylate (HEA).The photoinitiator can be 23 used to facilitate curing of the adhesive_ For example, the photoinitiator can be Darocur 4265 24 (a 50/50 blend of dipheny1(2,4,6-trimethylbenzoyflphosphine oxide and 2-hydroxy2-methylpropiophenone).
26 [0125] The first step in making the adhesive is preparation of a hydroxyl-functional polymer 27 precursor by photopolymerizing the cross-linkable polymer precursor formulation, thereby 28 yielding a cured composition. The second step is chemical conversion of the precursor 29 polymer pendant hydroxyl moieties, or hydroxyl pendant groups, into pendant methacrylate functional groups by reacting with a methacrylic anhydride or methacryloyl chloride, thus 31 forming a methacrylate-functional or methacrylic-functional cross-linkable polymer 1 comprising the alkyl acrylate or methacrylate (e.g., n-butyl acrylate), the fluoro-alkyl 2 (meth)acrylate (e.g., trifluoroethyl methacrylate), the phenyl-alkyl acrylate (phenylethyl 3 acrylate), and 2-(2-methyl-acryloyloxy)ethyl acrylate.
4 [0126] The methacrylic-functional cross-linkable polymer can be blended with a reactive acrylic monomer diluent such as 1-adamantyl methacrylate (ADMA) and the same 6 photoinitiator (e.g.. Darocur 4265). For example, the final composition of the adhesives 148 7 can comprise the cross-linkable polymer precursor formulation in the amount of about 50% to 8 about 85% (wt%) (e.g., about 61% to about 65%), the reactive acrylic monomer diluent in the 9 amount of about 10% to about 40% (wt%) (32% to about 36%), and the photoinitiator (e.g., Darocur 4265) in the amount of about 2% to about 3% (wt%).
11 [0127] The adhesives 148 or adhesive layer can bond, adhere, or otherwise join the anterior 12 element 106 to the posterior element 108. As will be discussed in more detail in the following 13 sections, the thickness of the adhesive layer can be adjusted post-implantation to adjust a base 14 power of the adjustable AIOL 100.
[0128] In some embodiments, the same adhesives 148 used to bond the anterior element 106 16 to the posterior element 108 can also be used to bond or affix the peripheral portion 103 (e.g., 17 the one or more haptics 104) to the optic portion 102.
18 [0129] In certain embodiments, the anterior optical surface 112 of the anterior element 106 can 19 be manufactured to have an aspherical optical surface prior to the adjustable AIOL 100 being implanted within the eye of the patient. In these embodiments, the anterior optical surface 112 21 can be aspheric regardless of any fluid pressure changes within the optic fluid chamber 110. In 22 these embodiments, the anterior optical surface 112 can also maintain its asphericity across all 23 base power changes.
24 [0130] In other embodiments, the posterior optical surface 116 of the posterior element 108 can be manufactured to have an aspherical optical surface prior to the adjustable AIOL 100 26 being implanted within the eye of the patient. In these embodiments, the posterior optical 27 surface 116 can be aspheric regardless of any fluid pressure changes within the optic fluid 28 chamber 110. In these embodiments, the posterior optical surface 116 can maintain its 29 asphericity across all base power changes.
[0131] In some embodiments, the anterior element 106 can have a thickness at its center or 31 central portion that is greater than a thickness at its periphery. In certain embodiments, the 1 posterior element 108 can also have a thickness at its center or central portion that is greater 2 than a thickness at its periphery.
3 [0132] As shown in Figs. 1B-1D, the optic portion 102 can have an optical axis 152. The 4 optical axis 152 can extend in an anterior-to-posterior direction through a center or center point of the optic portion 102. The optical axis 152 can extend through the centers or center points 6 of both the anterior element 106 and the posterior element 106.
7 [0133] The thickness of the anterior element 106 can be greater at the optical axis 152 or near 8 the optical axis 152 than at the periphery of the anterior element 106.
In some embodiments, 9 the thickness of the anterior element 106 can increase gradually from the periphery of the anterior element 106 toward the optical axis 152.
11 [0134] In certain embodiments, the thickness of the anterior element 106 at the optical axis 12 152 or near the optical axis 152 can be between about 0.45 mm and about 0.55 mm. In these 13 and other embodiments, the thickness of the anterior element 106 near the periphery can be 14 between about 0.20 mm and about 0.40 mm. This difference in thickness can contribute to the anterior optical surface 112 changing shape from a spherical surface configuration to an 16 aspherical surface configuration as fluid enters the fluid-filled optic fluid chamber 110 from 17 the haptic fluid chamber(s) 120.
18 [0135] Moreover, the anterior inner surface 114 of the anterior element 106 can have less 19 curvature or be flatter than the anterior optical surface 112. This difference in surface curvature between the anterior inner surface 114 and the anterior optical surface 112 can also 21 contribute to the anterior optical surface 112 changing shape from the spherical surface 22 configuration to the aspherical surface configuration as fluid enters the fluid-filled optic fluid 23 chamber 110 from the haptic fluid chamber(s) 120.
24 [0136] In other embodiments, the thickness of the posterior element 108 can be greater at the optical axis 152 or near the optical axis 152 than portions of the posterior element 108 radially 26 outward from the optical axis 152 but prior to reaching the raised inner surface 132. The 27 thickness of the posterior element 108 can gradually decrease from the optical axis 152 to 28 portions radially outward from the optical axis 152 (but prior to reaching the raised inner 29 surface 132). The thickness of the posterior element 108 can increase again from the beginning of the raised inner surface 132 to the peripheral edge 150.
1 [0137] In certain embodiments, the thickness of the posterior element 108 at the optical axis 2 152 or near the optical axis 152 can be between about 0.45 mm and about 0.55 mm. In these 3 and other embodiments, the thickness of the posterior element 108 radially outward from the 4 optical axis 152 (but prior to reaching the raised inner surface 132) can be between about 0.20 mm and about 0.40 mm. The thickness of the posterior element 108 near the peripheral edge 6 150 can be between about 1.00 mm and 1.15 mm. This difference in thickness can contribute 7 to the posterior optical surface 116 changing shape from the spherical surface configuration to 8 the aspherical surface configuration as fluid enters the fluid-filled optic fluid chamber 110 9 from the haptic fluid chamber(s) 120.
[0138] Moreover, the posterior inner surface 118 of the posterior element 108 can have less 11 curvature or be flatter than the posterior optical surface 116. This difference in surface 12 curvature between the posterior inner surface 118 and the posterior optical surface 116 can 13 also contribute to the posterior optical surface 116 changing shape from the spherical surface 14 configuration to the aspherical surface configuration as fluid enters the fluid-filled optic fluid chamber 110 from the haptic fluid chamber(s) 120.
16 [0139] Fig. 2A is a graphic representation of a composite material 200 comprising a composite 17 base material 202, an energy absorbing constituent 204, and a plurality of expandable 18 components 206. In some embodiments, the optic portion 102 of the adjustable AIOL 100 can 19 be made in part of the composite material 200. In other embodiments, the peripheral portion 103 of the adjustable AIOL 100 can be made in part of the composite material 200. In further 21 embodiments, both the optic portion 102 and the peripheral portion 103 of the adjustable 22 AIOL 100 can be made in part of the composite material 200.
23 [0140] The composite base material 202 can comprise a methacrylate-functional or 24 methacrylic-functional cross-linkable polymer and reactive acrylic monomer diluents including lauryl methacrylate (n-dodecyl methacrylate or SR313) and ADMA. By controlling 26 the amount of lauryl methacrylate (SR313) to ADMA, the overall corresponding hardness (i.e., 27 more ADMA) or softness (i.e., more SR313) of the cured composite material 200 can be 28 controlled. The methacrylate-functional or methacrylic-functional cross-linkable polymer can 29 be made using the cross-linkable polymer precursor formulation. The cross-linkable polymer precursor formulation can be the same cross-linkable polymer precursor formulation used as 31 part of the formulation for the adhesives 148.
1 [0141] As previously discussed, the optic portion 102 can comprise or be made in pan of the 2 lens body material. Also, as previously discussed, the peripheral portion 103 (e.g., the one or 3 more haptics 104) can comprise or be made in part of the haptic material.
The cross-linkable 4 polymer precursor formulation can comprise the same copolymer blend used to make the lens body material, the haptic material, or the adhesives.
6 [0142] The copolymer blend can comprise an alkyl acrylate or methacrylate (e.g., n-butyl 7 acrylate), a fluom-alkyl (meth)acrylate (e.g., trifluoroethyl methacrylate), and a phenyl-alkyl 8 acrylate (e.g., phenylethyl acrylate). For example, the copolymer blend can comprise n-butyl 9 acrylate in the amount of about 41% to about 45% (wt%), tfifluoroethyl methacrylate in the amount of about 20% to about 24% (wt%), and phenylethyl acrylate in the amount of about 11 28% to about 32% (wt%). As previously discussed, the cross-linkable polymer precursor 12 formulation can comprise or be made in part of the copolymer blend, a hydroxyl-functional 13 acrylic monomer (e.g., HEA), and a photoinitiator (e.g., Darocur 4265 or a 50/50 blend of 14 dipheny1(2,4,6-trimethylbenzoy1)-phosphine oxide and 2-hydroxy2-methylpropiophenone).
[0143] The composite base material 202 can comprise the methacrylate-functional or 16 methacrylic-functional cross-linkable polymer (as discussed above) in the amount of about 17 50% to about 65% (e.g., about 55% to about 60%) (wt%), the reactive acrylic monomer 18 diluent lauryl methacrylate (SR313) in the amount of about 32% to about 38% (e.g., about 19 32.70%) (wt%), the reactive acrylic monomer diluent adamantly methacrylate (ADMA) in the amount of about 5% to about 9% (e.g., about 7.30%) (wt%).
21 [0144] The composite material 200 can be made in several operations. The first operation can 22 comprise preparing an uncolored composite base material 202. The second operation can 23 comprise mixing the composite base material 202 with an energy absorbing constituent 204, 24 expandable components 206, and initiators such as one or more photoinitiators, thermal initiators, or a combination thereof. The third operation can comprise placing the uncured 26 composite material 200 into a desired location within the optic portion 102, the haptic(s) 104, 27 or a combination thereof, and curing the composite material 200 in place to form the adhered 28 composite material 200.
29 [0145] For example, the uncolored composite base material 202 can be mixed with an energy absorbing constituent 204 such as a dye (e.g., Disperse Red 1 dye) or pigment (graphitized 31 carbon black). The energy absorbing constituent 204 will be discussed in more detail below.
1 [0146] In some embodiments, the expandable components 206 can make up about 5.0% to 2 about 15.0% by weight of a final formulation of the composite material 200. More specifically, 3 the expandable components 206 can make up about 8.0% to about 12.0%
(e.g., about 10.0%) 4 by weight of a final formulation (see Table 1) of the composite material 200. In these and other embodiments, the energy absorbing constituent 204 can make up about 0.044% to about 6 0.44% (or about 0.55%) by weight of the final formulation of the composite material 200.
7 [0147] The photoinitiator can be Omnirad 2022 (bis(2,4,6-trimethylbenzoyl)phenyl-8 phosphineoxide/2-hydroxy-2-methyl-1- phenyl-propari-l-one). The photoinitiator can make up 9 about 1.30% by weight of a final formulation of the composite material 200 (see, e.g., Table 1). In addition, the composite material 200 can also comprise a thermal initiator. The thermal 11 initiator can make up about 1.00% by weight of a final formulation of the composite material 12 200 (see, e.g., Table 1). In some embodiments, the thermal initiator can be a dialkyl peroxide 13 such as Luperox peroxide. In other embodiments, the thermal initiator can be Perkadox.
14 [0148] Table 1 below provides an example formulation for the composite material 200:
TABLE 1: FORMULATION OF COMPOSITE MATERIAL (WT%) Cross-linkable polymer (in two 1.47% 2-hydroxyethyl acrylate (HEA) steps from precursor 1.96% Darocur 4265 (photoinitiator) formulation, as described above) 43.50% n-butylacrylate (nBA) 30.21% 2-phenylethylacrylate (PEA) 22.87% 2,2,2-trifluoroethylmethacrylate (TFEMA) Composite base material 60.00% cross-linkable polymer 32.70% lauryl methacrylate (SR313) 130% 1-adamantyl methacrylate (ADMA) Composite base material with 99.50% composite base material red energy absorbing colorant 0.50% Disperse Red 1 dye Composite base material with 99.95% composite base material black energy absorbing colorant 0.05% graphitized mesoporous carbon black Final formulation of 87.70% composite base material with red or black energy composite material absorbing colorant 10.00% expandable microspheres 1.00% Luperox peroxide (thermal initiator) 1.30% Omnirad 2022 2 [0149] Fig 2B illustrates that the expandable components 206 can be expandable microspheres 3 comprising an expandable thermoplastic shell 208 and a blowing agent 210 contained within 4 the expandable thermoplastic shell 208. The microspheres can be configured to expand such that a diameter 212 of at least one of the microspheres can increase about 2X
the original 6 diameter. In other embodiments, the microspheres can be configured to expand such that the 7 diameter 212 of at least one of the microspheres can increase about 4X or four times the 8 original diameter. In further embodiments, the microspheres can be configured to expand such 9 that the diameter 212 of at least one of the microspheres can increase between about 2X and about 4X (or about 35X) the original diameter. For example, the microspheres can have a 11 diameter 212 of about 12 pm at the outset. In response to an external energy applied or 12 directed at the composite material 200 or in response to energy transferred or transmitted to the 13 microspheres, the diameter 212 of the microspheres can increase to about 40 pm.
14 [0150] The volume of at least one of the microspheres can be configured to expand between about ten times (10X) to about 50 times (50X) in response to the external energy applied or 16 directed at the composite material 20 or in response to energy transferred or transmitted to the 17 microspheres.
18 [0151] In some embodiments, the blowing agent 210 can be an expandable fluid, such as an 19 expandable gas. More specifically, the blowing agent 210 can be a branched-chain hydrocarbon. For example, the blowing agent 210 can be isopentane. In other embodiments, 21 the blowing agent 210 can be or comprise cyclopentane, pentane, or a mixture of 22 cyclopentane, pentane, and isopentane.
23 [0152] Fig. 213 illustrates that each of the expandable components 206 can comprise a 24 thermoplastic shell 208. Fig. 2B also illustrates that a thickness of the thermoplastic shell 208 can change as the expandable component 206 increases in size. More specifically, the 26 thickness of the thermoplastic shell 208 can decrease as the expandable component 206 27 increases in size. For example, when the expandable components 206 are expandable 28 microspheres, the thickness of the thermoplastic shell 208 (i.e., its thickness in a radial 29 direction) can decrease as the diameter 212 of the expandable microsphere increases.
[0153] For example, as previously discussed, at least one of the expandable microspheres can 31 have a diameter 212 of about 12 pm at the outset. In this embodiment, the thermoplastic shell 1 208 of the expandable microsphere can have a shell thickness of about 2.0 pm. In response to 2 an external energy applied or directed at the composite material 200 or in response to energy 3 transferred or transmitted to the microsphere, the diameter 212 of the microsphere can increase 4 to about 40 pm (and the volume expand between about 10X and 50X) and the shell thickness of the microsphere can decrease to about 0.1 pm.
6 [0154] Although Figs. 2A and 213 illustrate the expandable components 206 as spheres or 7 microspheres, it is contemplated by this disclosure that the expandable components 206 can be 8 substantially shaped as ovoids, ellipsoids, cuboids or other polyhedrons, or a combination 9 thereof.
[0155] In some embodiments, the thermoplastic shell 208 can be made in part of nitriles or 11 acrylonitrile copolymers. For example, the thermoplastic shell 208 can be made in part of 12 acrylonitrile, styrene, butadiene, methyl acrylate, or a combination thereof.
13 [0156] As previously discussed, the expandable components 206 can make up between about 14 8.0% to about 12% by weight of a final formulation of the composite material 200. The expandable components 206 can make up about 10% by weight of a final formulation of the 16 composite material 200.
17 [0157] The expandable components 206 can be dispersed or otherwise distributed within the 18 composite base material 202 making up the bulk of the composite material 200. The composite 19 base material 202 can serve as a matrix for holding or carrying the expandable components 206. The composite material 200 can expand in response to an expansion of the expandable 21 components 206 (e.g., the thermoplastic microspheres). For example, a volume of the 22 composite material 200 can increase in response to the expansion of the expandable 23 components 206.
24 [0158] The composite material 200 also comprises an energy absorbing constituent 204. In some embodiments, the energy absorbing constituent 204 can be an energy absorbing colorant.
26 [0159] In certain embodiments, the energy absorbing colorant can be an energy absorbing dye.
27 For example, the energy absorbing dye can be an azo dye. In some embodiments, the azo dye 28 can be a red azo dye such as Disperse Red 1 dye. In other embodiments, the azo dye can be an 29 orange azo dye such as Disperse Orange dye (e.g., Disperse Orange 1), a yellow azo dye such as Disperse Yellow dye (e.g., Disperse Yellow 1), a blue azo dye such as Disperse Blue dye 31 (e.g., Disperse Blue 1), or a combination thereof.
1 [0160] In additional embodiments, the energy absorbing colorant can be or comprise a 2 pigment. For example, the energy absorbing colorant can be or comprise graphitized carbon 3 black as the pigment.
4 [01611 Similar to the expandable components 206, the energy absorbing constituent 204 can be dispersed or otherwise distributed within the composite base material 202 making up the 6 bulk of the composite material 200. The composite base material 202 can serve as a matrix for 7 holding or carrying the expandable components 206 and the energy absorbing constituent 204.
8 [0162] As previously discussed, the energy absorbing constituent 204 can make up between 9 about 0.025% to about 1.0% (or, more specifically, about 0.045% to about 0.45%) by weight of a final formulation of the composite material 200. For example, when the energy absorbing 11 constituent 204 is a dye (e.g., an azo dye such as Disperse Red 1), the energy absorbing 12 constituent 204 can make up about between about 0.45% to about 1.0% by weight of a final 13 formulation of the composite material 200. When the energy absorbing constituent 204 is 14 graphitized carbon black or other types of pigments, the energy absorbing constituent 204 can make up about 0.025% to about 0.045% by weight of a final formulation of the composite 16 material 200.
17 [0163] The energy absorbing constituent 204 (e.g., azo dye, graphitized carbon black, or a 18 combination thereof) can absorb or capture an external energy applied or directed at the 19 composite material 200. The energy absorbing constituent 204 can absorb or capture the external energy and then transform or transfer the energy into thermal energy or heat to the 21 expandable components 206.
22 [0164] The thermoplastic shell 208 can soften and begin to flow as thermal energy is 23 transferred or transmitted to the expandable components 206. The thermoplastic shell 208 of 24 the expandable components 206 can then begin to thin or reduce in thickness in response to the thermal energy transferred or transmitted to the expandable components 206. As the 26 thermoplastic shell 208 begins to soften and reduce in thickness, the blowing agent 210 within 27 the expandable components 206 can expand. The blowing agent 210 can also expand in 28 response to the thermal energy or heat transferred or transmitted to the expandable components 29 206. Expansion of the blowing agents 210 can cause the expandable components 206 (e.g., the thermoplastic microspheres) to expand or increase in volume. This ultimately causes the 31 composite material 200 to expand or increase in volume.
1 [0165] The composite material 200 can expand or increase in size in an isotropic manner such 2 that the composite material 200 expands in all directions. Such isotropic expansion can be 3 harnessed to produce expansion or material displacement in specific directions by placing or 4 positioning the composite material 200 at specific locations along the haptic(s) 104 or optic portion 102 of the adjustable AIOL 100.
6 [0166] As will be discussed in more detail in the following sections, in some embodiments, 7 the external energy can be light energy and the energy absorbing constituent 204 can absorb or 8 capture the light energy directed at the composite material 200 and transform or transfer the 9 light energy into thermal energy or heat to the expandable components 206. The blowing agent 210 within the expandable components 206 can expand or become energized in response to the 11 thermal energy or heat. The expandable components 206 and, ultimately, the composite 12 material 200 can expand or increase in volume in response to this light energy directed at the 13 composite material 200.
14 [0167] The shape change (e.g., increase in volume) undertaken by the expandable components 206 can be a persistent change or a substantially permanent change. A
persistent change or 16 substantially permanent change can mean that the expandable components 206 do not 17 substantially revert back to its original shape or size after the shape change (e.g., after an 18 increase in volume) has occurred. As a result, any change in the size or volume of the 19 composite material 200 caused by a change in the size or volume of the expandable components 206 is also persistent or substantially permanent. As will be discussed in more 21 detail in the following sections, this means that any structural changes made to the adjustable 22 AIOL 100 as a result of external energy or stimulus applied or otherwise directed at the 23 composite material 200 embedded or integrated within the adjustable AIOL
100 can persist or 24 remain substantially permanent.
[0168] The thermoplastic shells 208 of the expandable components 206 can harden, once 26 again, when the external energy is no longer directed or applied to the composite material 200.
27 The thermoplastic shells 208 of the expandable components 206 can harden, once again, when 28 the temperature within a vicinity of the expandable components 206 falls below a certain 29 threshold. For example, the thermoplastic shells 208 of the expandable microspheres can harden when light energy is no longer directed at the composite material 200.
After the 1 thermoplastic shells 208 harden, the expandable components 206 are locked into their new size 2 and expanded configuration.
3 [0169] When the energy absorbing constituent 204 is an energy absorbing colorant, such as a 4 dye or graphitized carbon, the color of at least part of the composite material 200 can take on the color of the energy absorbing colorant. For example, when the energy absorbing 6 constituent 204 is an azo dye such as Disperse Red 1 having a red color, at least a portion of 7 the composite material 200 comprising the energy absorbing constituent 204 can be colored 8 red. Moreover, when the energy absorbing constituent 204 is graphitized carbon having a 9 black color, at least a portion of the composite material 200 comprising the energy absorbing constituent 204 can be colored black. Although two colors (e.g., red and black) are mentioned 11 in this disclosure, it is contemplated by this disclosure and it should be understood by one of 12 ordinary skill in the art that energy absorbing colorant of other types of colors can also be used 13 such as energy absorbing yellow, orange, or blue dyes or materials.
14 [0170] The color of the energy absorbing colorant can be visually perceptible to a clinician or another medical professional when the adjustable AIOL 100 is made in part of the composite 16 material 100 comprising the energy absorbing colorant. The color of the energy absorbing 17 colorant can be visually perceptible to a clinician or another medical professional when the 18 adjustable AIOL 100 is implanted within an eye of a patient. For example, the composite 19 material 200 can comprise Disperse Red 1 serving as the energy absorbing colorant. In this example, at least part of the adjustable AIOL 100 can appear red to the clinician or another 21 medical professional when the adjustable AIOL 100 is implanted within the eye of a patient.
22 [0171] The color of the energy absorbing colorant can allow the clinician or another medical 23 professional detect or determine the location or position of the composite material 200 within 24 the adjustable AIOL 100. The color of the energy absorbing colorant can also allow the clinician or another medical professional to determine where to direct the external energy or 26 stimulus to adjust the adjustable AIOL 100.
27 [0172] As will be discussed in more detail in the following sections, at least part of the 28 adjustable AIOL 100 can be made of a composite material 200 comprising an energy 29 absorbing constituent 204 of a first color (e.g., red) and another part of the adjustable AIOL
100 can be made of additional composite material 200 comprising an energy absorbing 31 constituent 204 of a second color (e.g., black). By designing the adjustable AIOL 100 in this 1 manner, a clinician or another medical professional can direct external energy or stimulus at 2 different parts of the adjustable AIOL 100 using the different colors of the composite materials 3 200 as guides or markers for distinguishing between different locations of such target sites.
4 Moreover, the different colored composite materials 200 can also serve as indicators or visual cues as to where to direct the external energy or stimulus to cause certain changes in one or 6 more optical parameters (e.g., the base power, the cylindricity, or a combination thereof) of the 7 adjustable AIOL 100.
8 [0173] One technical problem faced by the applicants is how to integrate an adjustable 9 composite material into an optic portion and a peripheral portion (e.g., the haptics) of an AIOL
such that the adjustable composite material would adhere to the lens material used to make the 11 rest of the AIOL and remain substantially fixed at certain locations within the optic portion or 12 peripheral portion. One solution discovered by the applicants and disclosed herein is the 13 unique composition of the composite material which incorporates the same copolymer blend 14 used to make the lens body material and the haptic material. Moreover, the composite material is made in part in the cross-linkable polymer precursor formulation used in the adhesive for 16 adhering parts of the AIOL to one another_ By designing the AIOL in this manner, the 17 composite material is compatible with the rest of the material used to construct the optic 18 portion and the peripheral portion and remains substantially fixed at its location without 19 migrating or shifting.
[0174] Another technical problem faced by the applicants is how to ensure that any 21 adjustments made to the AIOL persist long after the adjustment procedure. One solution 22 discovered by the applicants and disclosed herein is to induce an expansion of a composite 23 material made in part of expandable microspheres comprising a blowing agent contained 24 within thermoplastic shells. The thermoplastic shells can soften (and the thickness of the thermoplastic shells can decrease) in response to an external energy directed or applied at the 26 composite material (which can result in heat or thermal energy being transferred or transmitted 27 to the expandable microspheres). The blowing agent within the thermoplastic shells can 28 expand as the thermoplastic shells soften. Expansion of the blowing agent can expand the 29 microspheres, which can, in turn, expand the composite base material serving as the bulk of the composite material. The expandable microspheres can retain their new enlarged or 1 expanded configuration even after the external energy is no longer applied to the composite 2 material.
3 [0175] Moreover, the composite material also comprises an energy absorbing constituent such 4 as an energy absorbing dye or colorant. The energy absorbing constituent can capture or absorb a relatively harmless external energy or stimulus directed at the composite material and 6 transform or transfer the external energy into thermal energy which can then cause the 7 thermoplastic microspheres to expand. By designing the adjustable AIOL
100 in this manner, 8 one or more bursts or pulses of relatively harmless energy or stimulus (e.g., light energy) can 9 be used to induce a persistent change in the shape or size of at least part of the adjustable AIOL 100. This persistent change in the shape or size of the adjustable AIOL
100 can have a 11 continuing effect on an optical parameter of the lens including, for example, its base power.
12 [0176] Figs. 3A and 3B illustrate sectional views of an embodiment of the adjustable AIOL
13 100 comprising an expandable spacer 300 made at least in part of the composite material 200.
14 The expandable spacer 300 can be positioned or otherwise disposed in a radially inner portion 146 of the peripheral portion 103 (e.g., a haptic 104) of the adjustable AIOL
NO.
16 [0177] As shown in Figs. 3A and 313, the radially inner portion 146 of the haptic 104 can be 17 radially thicker or bulkier than the radially outer portion 144. Figs.
3A and 3B also illustrate 18 the adjustable AIOL 100 as being implanted within an eye of a patient and, more specifically, 19 as being positioned within a capsular bag 304 of the patient (shown in Figs. 3A and 3B using broken lines). The radially outer portion 144 of the haptic 104 can come into physical contact 21 or push against an inner surface of the capsular bag 304 when the adjustable AIOL 100 is 22 positioned within the capsular bag 304.
23 [0178] As shown in Figs. 3A and 313, the expandable spacer 300 can be positioned partially 24 within the radially inner portion 146 of the haptic 104. In some embodiments, at least part of the expandable spacer 300 can jut out or extend out radially inward or laterally toward the 26 outer peripheral surface 142 of the optic portion 102. In these and other embodiments, at least 27 part of the expandable spacer 300 can be positioned in between the haptic 104 and the optic 28 portion 102. More specifically, the expandable spacer 300 can be positioned in between (e.g., 29 radially in between) the optic portion 102 and the haptic fluid chamber 120.
[0179] In some embodiments, the expandable spacer 300 can be adhered to the radially inner 31 portion 146 of the haptic 104 by being cured into place. For example, the expandable spacer 1 300 can be adhered to a furrow, indentation, or groove formed along the radially inner portion 2 146.
3 [0180] In other embodiments, the expandable spacer 300 can be positioned entirely within the 4 radially inner portion 146 of the haptic 104. In some embodiments, a cavity, conduit, or other void space can be formed within the radially inner portion 146 and the expandable spacer 300 6 can be introduced into the cavity, conduit, or void space and cured into place.
7 [0181] In further embodiments, the expandable spacer 300 can refer to part of the peripheral 8 portion 103 (e.g., the haptic 104) made of the composite material 200.
For example, the 9 expandable spacer 300 can refer to part of the radially inner portion 146 of the haptic 104 made of the composite material 200.
11 [0182] Although Figs. 3A and 3B illustrate the expandable spacer 300 as having a rectangular 12 cross-sectional profile, it is contemplated by this disclosure and it should be understood by one 13 of ordinary skill in the art that the cross-sectional profile of the expandable spacer 300 can be 14 substantially shaped as an oval, a circle, triangular or another polygon.
[0183] Figs. 3A and 3B also illustrate that an external energy 302 can be directed or otherwise 16 applied to the expandable spacer 300 to induce a shape change in the expandable spacer 300 17 (e.g., enlarge the expandable spacer 300) to affect an optical parameter of the adjustable AIOL
18 100.
19 [0184] In some embodiments, the external energy 302 can be light energy.
More specifically, the external energy 302 can be laser light. In certain embodiments, the laser light can have a 21 wavelength between about 488 nm to about 650 nm. The external energy 302 can be one or 22 more bursts or pulses of laser light.
23 [0185] In some embodiments, the laser light can be green laser light.
The green laser light can 24 have a wavelength of between about 520 nm to about 570 nm. In one example, embodiment, the external energy 302 can be green laser light having a wavelength of about 532 nm.
26 [0186] For example, the laser light can be laser light emitted by an ophthalmic laser. For 27 example, the laser light can be laser light emitted by a retinal coagulation laser.
28 [0187] When the external energy 302 is light energy, the energy absorbing constituents 204 29 can absorb or otherwise capture the light energy and convert the light energy into thermal energy to cause the expandable components 206 within the composite material 200 to expand.
1 [0188] As shown in Fig. 3B, the external energy 302 can cause the expandable spacer 300 to 2 expand. Expansion of the expandable spacer 300 can cause the spacer 300 to push against the 3 outer peripheral surface 142 of the optic portion 102. For example, the enlarged expandable 4 spacer 300 can push against the posterior element 108 of the optic portion 102. Since the periphery of the posterior element 108 is relatively thick or bulky in between the outer 6 peripheral surface 142 and the raised inner surface 132, the enlarged expandable spacer 300 7 primarily exerts a radially outward force or laterally outward force on the haptic 104.
8 [0189] Fig. 3B illustrates that the haptic 104 can be biased or pushed against the sides of the 9 capsular bag 304. More specifically, the enlarged expandable spacer 300 can bias or push the radially inner portion 146 of the haptic 104 radially outward. For example, Fig. 3B illustrates 11 the radially outward displacement of the radially inner portion 146 of the haptic 104 using 12 solid lines to indicate the position of the radially inner portion 146 after the expansion and 13 broken-lines to indicate the position of the radially inner portion 146 prior to the expansion.
14 Given the limited amount of space within the capsular bag 304, this radially outward displacement of the radially inner portion 146 of the haptic 104 can cause the chamber walls of 16 the haptic fluid chamber 120 to compress or squeeze together, thereby decreasing a volume of 17 the haptic fluid chamber 120.
18 [0190] As previously discussed, both the haptic fluid chamber(s) 120 and the optic fluid 19 chamber 110 can be filled with a fluid (e.g., silicone oil). Decreasing the volume of the haptic fluid chamber 120 can cause at least some of the fluid within the haptic fluid chamber(s) 120 21 to flow from the haptic fluid chamber(s) 120 into the optic fluid chamber 120. Moreover, as 22 previously discussed, the haptic fluid chamber(s) 120 can be in fluid communication with the 23 optic fluid chamber 120 through a plurality of fluid channels 122 (including the first pair of 24 fluid channels 122A, the second pair of fluid channels 122B, or a combination thereof, see Fig.
1A). Although fluid flow between the haptic fluid chamber 120 and the optic fluid chamber 26 120 is shown in Fig. 3B using the curved arrow depicted using broken-lines, it should be 27 understood by one of ordinary skill in the art that fluid flows from the haptic fluid chamber(s) 28 120 to the optic fluid chamber 120 via the plurality of fluid channels 122.
29 [0191] As previously discussed, the base power of the optic portion 102 can be configured to change based on an internal fluid pressure within the fluid-filled optic fluid chamber 110. The 1 base power of the optic portion 102 can be configured to increase as fluid enters the optic fluid 2 chamber 110 from the haptic fluid chamber(s) 120.
3 [0192] The optic portion 102 can also be configured to change shape in response to fluid 4 entering the optic fluid chamber 110. In certain embodiments, the anterior element 106 of the optic portion 102 can be configured to change shape (e.g., increase its curvature) in response to 6 the fluid entering the optic fluid chamber 110. In other embodiments, the posterior element 7 108 of the optic portion 102 can be configured to change shape (e.g., increase its curvature) in 8 response to the fluid entering the optic fluid chamber 110. In further embodiments, both the 9 anterior element 106 and the posterior element 108 can be configured to change shape in response to the fluid entering the optic fluid chamber 110. The base power of the optic portion 11 102 can be configured to increase in response to the shape change(s) undertaken by the 12 anterior element 106, the posterior element 108, or a combination thereof.
13 [0193] As depicted in Figs. 3A and 3B, when the expandable spacer 300 is positioned in 14 between the optic portion 102 and the haptic fluid chamber(s) 120, applying an external energy 302 to the expandable spacer 300 can cause an interaction between the haptic(s) 104 and a 16 capsular environment (e.g., the sides of the capsular bag 304) surrounding the haptic(s) 104.
17 This interaction between the haptic(s) 104 and the capsular environment can result in an 18 increase of the base power of the adjustable AIOL 100.
19 [0194] For example, adjusting a base power of the adjustable AIOL 100 can comprise directing or applying an external energy 302 (e.g., light energy between about 520 nm to about 21 570 nm) at the adjustable AIOL 100 implanted within an eye of the patient. More specifically, 22 the external energy 302 can be applied or directed at an expandable spacer 300 made in part of 23 the composite material 200. The expandable spacer 300 can expand in response to the 24 application of the external energy 302. Expansion of the spacer 300 can result in the haptic(s) 104 being pushed or biased radially or laterally outward against the sides of the capsular bag 26 304. This can result in the walls of the haptic fluid chamber 120 being compressed or squeezed 27 together such that a volume of the haptic fluid chamber 120 is reduced.
Fluid within the haptic 28 fluid chamber(s) 120 can then flow into the optic fluid chamber 110 in response to this 29 reduction in the volume of the haptic fluid chamber(s) 120. The base power of the optic portion 102 can increase in response to this fluid flow into the optic fluid chamber 110.
1 [0195] In some embodiments, bursts or pulses of external energy 302 (e.g., light energy) 2 directed at the expandable spacer 300 can result in an increase in the base power of the 3 adjustable AIOL 100 by between about +0.10 D and about +0.20 D (e.g., about +0.125 D). For 4 example, pulses of green laser light directed at the expandable spacer 300 can result in an increase in the base power of the adjustable AIOL 100 by between about +0.10 D
and about 6 +0.20 D (e.g., about +0.125 D). In some embodiments, the base power of the adjustable AIOL
7 100 can increase between about +1.0 D to about +5.0 D (e.g., about +2.0 D) in total in 8 response to bursts or pulses of the external energy 302 directed at the expandable spacer 300.
9 [0196] Figs. 4A and 4B are top and sectional views, respectively, of an embodiment of the adjustable AIOL 100 comprising the expandable spacer 300 extending radially inward toward 11 the optic portion 102 and occupying a gap space 400 in between the haptic(s) 104 and the optic 12 portion 102.
13 [0197] The adjustable AIOL 100 can be implanted within the capsular bag 304 (see Figs. 3A
14 and 3B) of the patient when positioned according to the configuration shown in Fig. 4A. The haptics 104 of the adjustable AIOL 100 can be curved around a periphery of the optic portion 16 102 with the free ends of the haptics 104 on almost opposing sides of the optic portion 102_ 17 [0198] As shown in Fig. 4A, the expandable spacer 300 can also be curved such that a radially 18 inward portion of the expandable spacer 300 follows or matches a curvature of the optic 19 portion 102. The expandable spacer 300 can extend along almost an entire length of each of the haptics 104.
21 [0199] Fig. 4B illustrates that the expandable spacer 300 can extend radially inward from the 22 radially inner portion 146 of the haptics 104 toward the optic portion 102. In some 23 embodiments, the expandable spacer 300 can be formed as a fin-like protrusion extending 24 radially inward from the radially inner portion 146 of the haptics 104.
In other embodiments, the expand spacer 300 can be substantially shaped as discontinuous segments of an annulus 26 positioned, at least partly, in between the optic portion 102 and the haptics 104.
27 [0200] As illustrated in Fig. 4B, the expandable spacer 300 can have an anterior-to-posterior 28 height. The anterior-to-posterior height of the expandable spacer 300 can be significantly less 29 than the anterior-to-posterior height of the haptic 104. Moreover, the expandable spacer 300 is relatively unconstrained in the anterior and posterior directions such that any expansion of the 31 spacer 300 primarily exerts a radially outward force or pressure on the haptics 104. Such 1 expansion exerts relatively little force or pressure on the haptics 104 in the anterior-to-2 posterior direction.
3 [0201] In some embodiments, the expandable spacer 300 can have a spacer anterior-to-4 posterior height of between about 0.10 mm to about 1.00 mm. The expandable spacer 300 can also have a spacer radial width. The spacer radial width can be between about 0.50 mm to 6 about 1.0 mm. In comparison, the haptic fluid chamber 120 can have a haptic fluid chamber 7 anterior-to-posterior height of between about 2.0 mm to about 3.0 mm.
Moreover, the haptic 8 fluid chamber 120 can have a haptic fluid chamber radial width of between about 0.8 mm to 9 about 1.1 mm.
[0202] Figs. 5A and 5B illustrate sectional views of another embodiment of the adjustable 11 AIOL 100 comprising an expandable spreader 500 made at least in part of the composite 12 material 200. The expandable spreader 500 can be positioned or otherwise disposed in the 13 radially inner portion 146 of the peripheral portion 103 (e.g., the haptic(s) 104, as shown in 14 Figs. 5A and 513). The radially inner portion 146 of the haptic(s) 104 can be radially thicker or builder than the radially outer portion 144.
16 [0203] As shown in Figs. SA and 5B, the expandable spreader 500 can be positioned within a 17 channel 502 or opening defined within the radially inner portion 146 of the haptic 104. In 18 some embodiments, the channel 502 or opening can extend along the entire length of the 19 haptic 104. In other embodiments, the channel 502 or opening can extend partly along the length of the haptic 104. The channel 502 or opening can be in fluid communication with the 21 haptic fluid chamber 120.
22 [0204] In some embodiments, the expandable spreader 500 can occupy all of the space within 23 the channel 502 or opening except for a gap 504 or void space between the expandable 24 spreader 500 and the outer peripheral surface 142 of the optic portion 102. In further embodiments, the gap 504 or void space can be replaced with the haptic material.
26 [0205] In other embodiments, the expandable spreader 500 can occupy at least some of the 27 space within the channel 502 (for example, the expandable spreader 500 is positioned in a 28 radially middle portion of the channel 502 or opening). In these embodiments, a gap 504 or 29 void space or additional haptic material can separate (e.g., separate in a radial direction) the expandable spreader 500 from the outer peripheral surface 142 of the optic portion 102. In all 31 such embodiments, the expandable spreader 500 can be located or positioned such that 1 expansion of the expandable spreader 500 does not cause the radially inner portion 146 of the 2 haptic 104 or the expander spreader 500 to substantially impinge on or push against the outer 3 peripheral surface 142 of the optic portion 102 (thereby preventing the haptic(s) 104 from 4 being pushed against the sides of the capsular bag 304, which can cause deformation of the haptic(s) 104 and affect the volume of the haptic fluid chamber(s) 120). For example, the 6 expandable spreader 500 can be located or positioned such that expansion of the expandable 7 spreader 500 does not result in the squeezing together or compression of the haptic chamber 8 walls of the haptic fluid chamber 120 (or does not result in the reduction of the volume of the 9 haptic fluid chamber 120).
[0206] In some embodiments, the expandable spreader 500 can be adhered to the radially inner 11 portion 146 of the haptic 104 by being cured into place within the channel 502 or opening. For 12 example, the expandable spreader 500 can be adhered to a location or position at the middle 13 portion of the channel 502 or opening.
14 [0207] In further embodiments, the expandable spreader 500 can refer to part of the peripheral portion 103 (e.g., part of the haptic 104) made of the composite material 200.
For example, the 16 expandable spreader 500 can refer to part of the radially inner portion 146 of the haptic 104 17 made of the composite material 200.
18 [0208] Although Figs. 5A and 5B illustrate the expandable spreader 500 as having a 19 rectangular cross-sectional profile, it is contemplated by this disclosure and it should be understood by one of ordinary skill in the art that the cross-sectional profile of the expandable 21 spreader 500 can be substantially shaped as an oval, a circle, triangular or other polygon.
22 [0209] Figs. 5A and 5B illustrate that an external energy 302 can be directed or otherwise 23 applied to the expandable spreader 500 to induce a shape change in the expandable spreader 24 500 (e.g., enlarge the expandable spreader 500) to affect an optical parameter of the adjustable AIOL 100.
26 [0210] In some embodiments, the external energy 302 is light energy such as a laser light. In 27 certain embodiments, the laser light can have a wavelength between about 488 nm to about 28 650 nm. The external energy 302 can be one or more bursts or pulses of laser light. In some 29 embodiments, the laser light can be green laser light.
1 [0211] When the external energy 302 is light energy, the energy absorbing constituents 204 2 can absorb or otherwise capture the light energy and convert the light energy into thermal 3 energy to cause the expandable components 206 within the composite material 200 to expand.
4 [0212] As shown in Fig. 5B, the external energy 302 can cause the expandable spreader 500 to expand. Expansion of the expandable spreader 500 can cause the spreader 500 to push against 6 channel walls 506 of the channel 502 defined within the radially inner portion 146 of the 7 haptic 104.
8 [0213] Fig. 5B illustrates that the enlarged spreader 500 can expand or spread apart the 9 channel walls 506 to expand or spread apart the channel 502. Moreover, the enlarged spreader 500 can also deform the chamber walls of the haptic fluid chamber 120 by spreading apart at 11 least some of the chamber walls, thereby enlarging the volume of the haptic fluid chamber 12 120.
13 [0214] The enlarged expandable spreader 500 can bias or push apart the channel walls 506 of 14 the channel 502, at least in an anterior-to-posterior direction. This can result in an increase in the volume of the haptic fluid chamber 120. For example, Fig. 5B illustrates the spread apart 16 channel walls 506 and haptic chamber walls using solid lines and the position of the channel 17 walls 506 and haptic chamber walls prior to expansion using broken-lines. Fig. 5B also 18 illustrates that the gap 504 or void space in between the spreader 500 and the optic portion 102 19 allows the spreader 500 to expand or increase in size without causing the spreader 500 to impinge on or push against the outer peripheral surface 142 of the optic portion 102 (thereby 21 preventing the haptic(s) 104 from being pushed against the sides of the capsular bag 304, 22 which can cause deformation of the haptic(s) 104 and affect the volume of the haptic fluid 23 chamber(s) 120). In other embodiments, additional haptic material can separate the spreader 24 500 from the outer peripheral surface 142 of the optic portion 102 such that expansion of the spreader 500 only spreads apart the channel walls 506 and chamber walls and does not cause 26 the radially outer portion 144 of the haptic(s) 104 to push against the sides of the capsular bag 27 304.
28 [0215] As previously discussed, both the haptic fluid chamber(s) 120 and the optic fluid 29 chamber 110 can be filled with a fluid (e.g., silicone oil). Increasing the volume of the haptic fluid chamber 120 can cause at least some of the fluid within the optic fluid chamber 110 to 31 flow from the optic fluid chamber 110 into the haptic fluid chamber(s) 120. Moreover, as 1 previously discussed, the haptic fluid chamber(s) 120 can be in fluid communication with the 2 optic fluid chamber 120 through a plurality of fluid channels 122 (including the first pair of 3 fluid channels 122A, the second pair of fluid channels 122B, or a combination thereof, see Fig.
4 1A). Although fluid flow between the haptic fluid chamber 120 and the optic fluid chamber 120 is shown in Fig. 5B using the curved arrow depicted using broken-lines, it should be 6 understood by one of ordinary skill in the art that fluid flows from the optic fluid chamber 110 7 to the haptic fluid chamber(s) 120 via the plurality of fluid channels 122.
8 [0216] As previously discussed, the base power of the optic portion 102 can be configured to 9 change based on an internal fluid pressure within the fluid-filled optic fluid chamber 110. The base power of the optic portion 102 can be configured to decrease as fluid enters the haptic 11 fluid chamber(s) 120 from the optic fluid chamber 110.
12 [0217] The optic portion 102 can also be configured to change shape in response to fluid 13 exiting the optic fluid chamber 110. In certain embodiments, the anterior element 106 of the 14 optic portion 102 can be configured to change shape (e.g., decrease its curvature) in response to the fluid exiting the optic fluid chamber 110. In other embodiments, the posterior element 16 108 of the optic portion 102 can be configured to change shape (e.g., decrease its curvature) in 17 response to the fluid exiting the optic fluid chamber 110. In further embodiments, both the 18 anterior element 106 and the posterior element 108 can be configured to change shape in 19 response to the fluid exiting the optic fluid chamber 110. The base power of the optic portion 102 can be configured to decrease in response to the shape change(s) undertaken by the 21 anterior element 106, the posterior element 108, or a combination thereof.
22 [0218] As depicted in Figs. 5A and 5B, applying an external energy 302 to the expandable 23 spreader 500 (e.g., when the expandable spreader 500 is positioned within a channel 502 or 24 opening defined within the radially inner portion 146 of the haptic(s) 104) can cause the volume of the haptic fluid chamber(s) 120 to increase. This increase in the volume of the 26 haptic fluid chamber(s) 120 can draw fluid out of the optic fluid chamber 110 and cause a 27 decrease in the base power of the adjustable AIOL 100.
28 [0219] For example, a method of decreasing a base power of the adjustable AIOL 100 can 29 comprise directing or applying an external energy 302 (e.g., light energy between about 520 nm to about 570 nm) at an expandable spreader 500 embedded within the adjustable AIOL 100 31 implanted within an eye of the patient. More specifically, the external energy 302 can be 1 applied or directed at an expandable spreader 500 made in part of the composite material 200.
2 The expandable spreader 500 can expand in response to the application of the external energy 3 302. Expansion of the spreader 500 can result in the volume of the haptic fluid chamber(s) 120 4 being enlarged. Fluid within the optic fluid chamber 110 can then flow into the haptic fluid chamber(s) 110 in response to this increase in the volume of the haptic fluid chamber(s) 120.
6 The base power of the optic portion 102 can decrease in response to this fluid flow out of the 7 optic fluid chamber 110.
8 [0220] In some embodiments, bursts or pulses of external energy 302 (e.g., light energy) 9 directed at the expandable spreader 500 can result in a decrease in the base power of the adjustable AIOL 100 by between about -0.10 D and about -0.20 D (e.g., about -0.125 D). For 11 example, pulses of green laser light directed at the expandable spreader 500 can result in a 12 decrease in the base power of the adjustable AIOL 100 by between about -0.10 D and 13 about -0.20 D (e.g., about -0.125 D). In some embodiments, the base power of the adjustable 14 AIOL 100 can decrease between about -1.0 D to about -5.0 D (e.g., about -2.0 D) in total in response to bursts or pulses of the external energy 302 directed at the expandable spreader 500.
16 [0221] Fig. 6 illustrates a sectional view of another embodiment of the adjustable AIOL 100 17 comprising an expandable protuberance 600 made at least in part of the composite material 18 200. The expandable protuberance 600 can be positioned or otherwise disposed along part of 19 the radially inner portion 146 of the peripheral portion 103 (e.g., the one or more haptics 104) of the adjustable AIOL 100.
21 [0222] As shown in Fig. 6, the haptic 104 (e.g., any of the first haptic 104A or the second 22 haptic 104B) can comprise haptic chamber walls surrounding the haptic fluid chamber 120.
23 For example, the haptic chamber walls can comprise a radially inner wall 602 and radially 24 outer wall 604. The haptic fluid chamber 120 can be defined in part by the radially inner wall 602 and the radially outer wall 604.
26 [0223] The expandable protuberance 600 can be positioned or otherwise disposed along part 27 of the radially inner wall 602 of the haptic 104. More specifically, the expandable 28 protuberance 600 can be positioned or otherwise disposed or affixed along a radially outermost 29 portion 606 of the radially inner wall 602 of the haptic 104.
[0224] In some embodiments, the adjustable AIOL 100 can be designed such that a gap or 31 void space 608 radially separates the radially inner wall 602 of the haptic 104 from the outer 1 peripheral surface 142 of the optic portion 102. This can ensure that neither the expandable 2 protuberance 600 nor the radially inner wall 602 impinges or pushes against the outer 3 peripheral surface 142 of the optic portion 102 when the expandable protuberance 600 expands 4 (thereby preventing the haptic(s) 104 from being pushed against the sides of the capsular bag 304, which can cause deformation of the haptic(s) 104 and affect the volume of the haptic fluid 6 chamber(s) 120). As previously discussed, when the radially inner portion 146 of the haptic 7 104 pushes against the outer peripheral surface 142 of the optic portion 102, the haptic 8 chamber walls can compress or squeeze together as a result of the radially outer wall 604 of 9 the haptic 104 pressing against the sides of the capsular bag 304 of the patient. In other embodiments, the adjustable AIOL 100 can be designed such that the radially inner wall 602 11 of the haptic 104 continuously rests against the outer peripheral surface 142 of the optic 12 portion 102 or intermittently rests against the outer peripheral surface 142 of the optic portion 13 102.
14 [0225] In some embodiments, for example, as shown in Fig. 6, the entire expandable protuberance 600 can be positioned below (or above) a halfway line or haptic midline 610. The 16 halfway line or haptic midline 610 can bisect the anterior-to-posterior height of the haptic 104 17 In these embodiments, no part of the expandable protuberance 600, in an unexpanded state, 18 can extend beyond the haptic midline 610. An anterior-to-posterior height of the expandable 19 protuberance 600 can be less than the anterior-to-posterior height of the radially inner wall 602.
21 [0226] In some embodiments, the expandable protuberance 600 can be adhered to the radially 22 inner portion 146 (e.g., the radially inner wall 602) of the haptic 104 by being cured into place.
23 For example, the expandable protuberance 600 can be adhered to a cavity, furrow, or groove 24 formed along the radially outermost portion 606 of the radially inner wall 602. In these instances, the expandable protuberance 600 can take up or occupy less than half the anterior-26 to-posterior height of the radially inner wall 602.
27 [0227] In further embodiments, the expandable protuberance 600 can refer to part of the 28 radially inner portion 146 (e.g., part of the radially inner wall 602) made of the composite 29 material 200. For example, the expandable protuberance 600 can refer to a part of the radially outermost portion 606 of the radially inner wall 602 made of the composite material 200.
1 [0228] Although Fig. 6 illustrates the cross-sectional profile of the expandable protuberance 2 600 as having primarily straight edges and corners, it is contemplated by this disclosure and it 3 should be understood by one of ordinary skill in the art that the cross-sectional profile of the 4 expandable protuberance 600 can also have rounded or curved edges and corners.
[0229] Fig. 6 also illustrate that an external energy 302 can be directed or otherwise applied to 6 the expandable protuberance 600 to induce a shape change in the expandable protuberance 600 7 (e.g., enlarge the expandable protuberance 600) to affect an optical parameter of the adjustable 8 AIOL 100.
9 [0230] The external energy 302 can be the same external energy 302 as previously disclosed.
For example, when the external energy 302 is light energy, the energy absorbing constituents 11 204 can absorb or otherwise capture the light energy and convert the light energy into thermal 12 energy to cause the expandable components 206 within the composite material 200 to expand.
13 [0231] As shown in Fig. 6, the external energy 302 can cause the expandable protuberance 600 14 to expand (as depicted by the enlarged protuberance 600 shown in broken lines). Expansion of the expandable protuberance 600 can cause the protuberance 600 to encroach, extend, or 16 otherwise grow into the fluid-filled haptic fluid chamber 120. This can cause fluid within the 17 haptic fluid chamber 120 to be displaced or pushed So the optic fluid chamber 110 (through 18 the plurality of fluid channels 122). Moreover, when the protuberance 600 expands and part of 19 the protuberance 600 encroaches, extends, or grows into the haptic fluid chamber 120, the fluid carrying capacity or the available volume of the haptic fluid chamber 120 can decrease.
21 [0232] As previously discussed, both the haptic fluid chamber(s) 120 and the optic fluid 22 chamber 110 can be filled with a fluid (e.g., silicone oil). Reducing the fluid carrying capacity 23 or the available volume of the haptic fluid chamber 120 can cause at least some of the fluid 24 within the haptic fluid chamber(s) 120 to flow from the haptic fluid chamber(s) 120 into the optic fluid chamber 120, and remain in the optic fluid chamber 120. Although fluid flow 26 between the haptic fluid chamber 120 and the optic fluid chamber 120 is shown in Fig. 6 using 27 the curved arrow depicted using broken-lines, it should be understood by one of ordinary skill 28 in the art that fluid flows from the haptic fluid chamber(s) 120 to the optic fluid chamber 120 29 via the plurality of fluid channels 122.
[0233] As previously discussed, the base power of the optic portion 102 can be configured to 31 change based on an internal fluid pressure within the fluid-filled optic fluid chamber 110. The 1 base power of the optic portion 102 can be configured to increase as fluid enters the optic fluid 2 chamber 110 from the haptic fluid chamber(s) 120.
3 [0234] The optic portion 102 can also be configured to change shape in response to fluid 4 entering the optic fluid chamber 110. In certain embodiments, the anterior element 106 of the optic portion 102 can be configured to change shape (e.g., increase its curvature) in response to 6 the fluid entering the optic fluid chamber 110. In other embodiments, the posterior element 7 108 of the optic portion 102 can be configured to change shape (e.g., increase its curvature) in 8 response to the fluid entering the optic fluid chamber 110. In further embodiments, both the 9 anterior element 106 and the posterior element 108 can be configured to change shape in response to the fluid entering the optic fluid chamber 110. The base power of the optic portion 11 102 can be configured to increase in response to the shape change(s) undertaken by the 12 anterior element 106, the posterior element 108, or a combination thereof.
13 [0235] In some embodiments, bursts or pulses of external energy 302 (e.g., light energy) 14 directed at the expandable protuberance 600 can result in an increase in the base power of the adjustable AIOL 100 by between about +0.10 D and about +0.20 D (e.g., about +0.125 D). For 16 example, pulses of green laser light directed at the expandable protuberance 600 can result in 17 an increase in the base power of the adjustable AIOL 100 by between about +0.10 D and about 18 +0.20 D (e.g., about +0.125 D). In some embodiments, the base power of the adjustable AIOL
19 100 can increase between about +1.0 D to about +5.0 D (e.g., about +2.0 D) in total in response to bursts or pulses of the external energy 302 directed at the expandable protuberance 21 600.
22 [0236] Figs. 7A and 7B illustrate top and sectional views, respectively, of another embodiment 23 of the adjustable AIOL 100 comprising both an expandable spreader 500 and an expandable 24 protuberance 600 making up at least part of each of the haptics 104. For example, as shown in Fig. 7A, a first haptic portion made of the expandable spreader 500 can be positioned or 26 adhered to one part of the haptic chamber wall and a second haptic portion made of the 27 expandable protuberance 600 can be positioned or adhered to another part of the same "'optic 28 chamber wall.
29 [0237] In some embodiments, the first haptic portion (e.g., the expandable spreader 500) can be made in part of a first composite material, or a first type of the composite material 200 31 shown in Fig. 2A, and the second haptic portion (e.g., the expandable protuberance 600) can 1 be made in part of a second composite material, or a second type of the composite material 200 2 shown in Fig. 2A.
3 [0238] In some embodiments, the first composite material can be made in part of a first energy 4 absorbing constituent (e.g., a first type of the energy absorbing constituent 204 shown in Fig.
2A) and the second composite material can be made in part of a second energy absorbing 6 constituent (e.g., a second type of the energy absorbing constituent 204 shown in Fig. 2A). For 7 example, the first composite material can be made in part of Disperse Red 1 dye and the 8 second composite material can be made in part of graphitized carbon black. The first energy 9 absorbing constituent can have or exhibit a first color (e.g., the Disperse Red 1 dye can have or exhibit a red color) and the second energy absorbing constituent can have or exhibit a second 11 color (e.g., the graphitized carbon black can have or exhibit a black color) different from the 12 first color. Also, as another example, the first energy absorbing constituent can be an azo dye 13 having a first color (e.g., Disperse Red 1 dye) and the second energy absorbing constituent can 14 be another azo dye having a second color (e.g., Disperse Orange 1 dye).
This difference in color can allow a clinician or another medical professional to visually differentiate between the 16 two haptic portions.
17 [0239] In certain embodiments, the first composite material made in part of the first energy 18 absorbing constituent can expand in response to a first type of external energy (e.g., light 19 energy between 520 nm to 540 nm) directed at the first composite material and the second composite material made in part of the second energy absorbing constituent can expand in 21 response to a second type of external energy (e.g., light energy between 600 nm and 650 nm) 22 directed at the second energy absorbing constituent. In these and other embodiments, the first 23 energy absorbing constituent can have or exhibit a first color (e.g., red color) and the second 24 energy absorbing constituent can have or exhibit a second color (e.g., an orange or blue color) different from the first color.
26 [0240] In other embodiments, the first composite material and the second composite material 27 can be made in part of the same energy absorbing constituents but comprise different amounts 28 or weight percentages of such constituents. In other embodiments, the first composite material 29 and the second composite material can be made in part of the same energy absorbing constituents but comprise different amounts or weight percentages of expandable components 31 206.
1 [0241] As shown in Fig. 7A, the first haptic portion made in part of the first composite 2 material can be positioned or located radially offset from the second haptic portion made in 3 part of the second composite material. For example, the expandable spreader 500 can be 4 positioned radially offset from the expandable protuberance 600 on each of the haptics 104.
More specifically, a radially innermost portion of the haptic 104 can be made in part of the 6 expandable spreader 500 and an adjoining portion of the haptic radially outward from the 7 expandable spreader 500 can be made in part of the expandable protuberance 600.
8 [0242] Also, as shown in Fig. 7A, the expandable spreader 500 can extend along part of a 9 length of the haptic 104. Moreover, the expandable protuberance 600 can also extend along part of the length of the haptic 104.
11 [0243] Fig. 7B illustrates that the same radially inner wall 602 of the haptic 104 can comprise 12 both an expandable spreader 500 and an expandable protuberance 600. In the embodiment 13 shown in Fig. 7B, the expandable spreader 500 can be made in part of a first composite 14 material (e.g., a composite material 200 comprising a first energy absorbing colorant) and the expandable protuberance 600 can be made in part of a second composite material (e.g., a 16 composite material 200 comprising a second energy absorbing colorant).
The difference in the 17 color of the energy absorbing colorants can allow a clinician or another medical professional to 18 more easily distinguish the expandable spreader 500 and the expandable protuberance 600. In 19 other embodiments (for example, as depicted in Fig. 9B), the expandable spreader 500 and the expandable protuberance 600 can be made of the same composite material 200.
21 [0244] The expandable spreader 500 can be positioned within a channel 502 or opening 22 defined within the radially inner wall 602. The channel 502 or opening can be in fluid 23 communication with the haptic fluid chamber 120.
24 [0245] In some embodiments, the expandable spreader 500 can occupy a radially innermost portion 700 of the radially inner wall 602 of the haptic 104. In these embodiments, the 26 expandable spreader 500 can also occupy or be disposed at a radially innermost end of the 27 channel 502. In further embodiments, the expander spreader 500 can refer to part of a haptic 28 chamber wall of the haptic 104 made of the composite material 200. For example, in these 29 embodiments, the expander spread 500 can refer to part of the radially innermost portion 700 of the radially inner wall 602 of the haptic 104 made of the composite material 200.
1 [0246] As shown in Fig. 7B, a void space 608 or gap can separate the radially innermost 2 portion 700 of the radially inner wall 602 of the haptic 104 from the outer peripheral surface 3 142 of the optic portion 102. This can allow the expandable spreader 500 to expand without 4 impinging on or pushing up against the outer peripheral surface 142 of the optic portion 102.
[0247] As further shown in Fig. 7B, the expandable protuberance 600 can be positioned or 6 otherwise disposed or affixed along a radially outermost portion 606 of the radially inner wall 7 602 of the haptic 104. In certain embodiments, the expandable protuberance 600 can refer to 8 part of the haptic chamber wall made of the composite material 200. For example, the 9 expandable protuberance 600 can refer to part of the radially outermost portion 606 of the radially inner wall 602 of the haptic 104 made of the composite material 200.
11 [0248] External energy 302 directed or otherwise applied to the expander spreader 500 12 positioned along the haptic chamber wall (e.g., positioned along the radially innermost portion 13 700 of the radially inner wall 602 of the haptic 104) can cause the expandable spreader 500 to 14 expand. Expansion of the expandable spreader 500 can cause the spreader 500 to push against the channel walls 506 of the channel 502 and enlarge at least one of the channel 502 and the 16 haptic fluid chamber 120. This can cause the volume of the haptic fluid chamber(s) 120 to 17 increase. This can then draw fluid out of the optic fluid chamber 110 into the haptic fluid 18 chamber(s) 120 (via the fluid channels 122) and cause a decrease in the base power of the 19 adjustable AIOL 100 (e.g., a decrease between about -0.10 D and -0.20 D).
[0249] The same external energy 302 or another type of external energy 302 (e.g., light energy 21 of another wavelength) can also be directed or otherwise applied to the expandable 22 protuberance 600 positioned along the haptic chamber wall (e.g., positioned along the radially 23 outermost portion 606 of the radially inner wall 602 of the haptic 104).
The external energy 24 can cause the expandable protuberance 600 to expand. Expansion of the expandable spreader 500 can cause the protuberance 600 to encroach, extend, or otherwise grow into the fluid-filled 26 haptic fluid chamber 120. This can cause fluid within the haptic fluid chamber 120 to be 27 displaced or pushed into the optic fluid chamber 110 (through the plurality of fluid channels 28 122). Bursts or pulses of external energy 302 (e.g., light energy) directed at the expandable 29 protuberance 600 can result in an increase in base power of the adjustable AIOL 100 by between about +0.10 D and +0.20 D.
1 [0250] Fig. 8 illustrates a top plan view of another embodiment of the adjustable AIOL 100 2 comprising both expandable spreaders 500 and expandable protuberances 600 implemented as 3 discrete components 800 along the haptics 104. In alternative embodiments, at least one of the 4 expandable spreaders 500 and the expandable protuberances 600 can be replaced with expandable spacers 300 (see Figs. 3A and 3B).
6 [0251] In some embodiments, the expandable spreaders 500 can occupy or be positioned along 7 a radially innermost portion 700 (see, Fig. 7B) of the radially inner wall 602 of the haptic(s) 8 104. The expandable protuberances 600 can occupy or be positioned along a radially 9 outermost portion 606 (see, Fig. 6) of the radially inner wall 602 of the haptic(s) 104.
[0252] At least one of the expandable spreaders 500 and the expandable protuberances 600 11 can be implemented or configured as discrete components 800 visually perceptible to a 12 clinician or another medical professional responsible for adjusting the adjustable AIOL 100 13 when the adjustable AIOL 100 is implanted within an eye of a patient.
14 [0253] The discrete components 800 can refer to a shape or configuration of the expandable spreaders 500, the expandable protuberances 600, or a combination thereof. In some 16 embodiments, the discrete components 800 can have a circular profile when viewed from the 17 top down or when viewed in an anterior to posterior direction. In these embodiments, each of 18 the discrete components 800 can be shaped substantially as a cylinder.
In other embodiments 19 not shown in the figures, the discrete components 800 can have an oval profile, a rectangular profile, a triangular profile, a diamond or rhombus profile, a star profile, any other polygonal 21 profile, or a combination thereof when viewed from the top down or when viewed in an 22 anterior to posterior direction. The discrete components 800 can be spaced close apart or each 23 of the discrete components 800 can be separated from one another by portions of the haptic 24 material.
[0254] Moreover, as shown in Fig. 8, a portion or segment of one haptic 104 can comprise the 26 expandable spreaders 500 and another portion or segment of the same haptic 104 can comprise 27 the expandable protuberances 600. For example, a distal segment 802 of each of the haptics 28 104 (e.g., a segment 802 closer to the closed free end 138 of the haptics 104) can comprise the 29 expandable spreaders 500 and a proximal segment 804 of each of the haptics 104 (e.g., a segment 804 closer to the optic portion 102) can comprise the expandable protuberances 600.
31 As shown in Fig 8, the expandable protuberances, implemented as discrete components 800, 1 can be radially offset or radially separated from the expandable spreaders 500, also 2 implemented as discrete components 800.
3 [0255] Designing or otherwise configuring at least one of the expandable spreaders 500 and 4 the expandable protuberances 600 as discrete components 800 can allow a clinician or medical professional to fine tune the adjustment of the adjustable AIOL 100. For example, the clinician 6 or medical professional can direct the external energy 302 at one of the discrete components 7 800 to either increase the base power of the adjustable AIOL 100 (when the discrete 8 component 800 is an expandable protuberance 600) or decrease the base power of the 9 adjustable AIOL 100 (when the discrete component 800 is an expandable spreader 500) by a set amount. More specifically, in certain embodiments, the discrete components 800 can be 11 sized, shaped, or located to allow bursts or pulses of the external energy 302 applied to each of 12 the discrete components 800 to adjust an optical parameter (e.g., a base power) of the 13 adjustable AIOL 100 by a predetermined or preset amount. For example, bursts or pulses of 14 the external energy 302 applied to or directed at each of the discrete components 800 can cause a change in the base power by about 0.10 D and 0.20 D (e.g., about 0.125 D).
16 [0256] Moreover, in this example, the clinician or medical professional can also direct further 17 bursts or pulses of the external energy 302 at the same discrete component 800 to further 18 increase or decrease the base power of the adjustable AIOL 100 or direct further bursts or 19 pulses of the external energy 302 at a different discrete component 800 to undo or negate a previous adjustment (for example, to decrease the base power after an increase of the base 21 power has been induced).
22 [0257] Although Fig. 8 illustrates the haptic(s) 104 comprising both the expandable spreaders 23 500 and the expandable protuberances 600 (configured as discrete components 800), it is 24 contemplated by this disclosure and it should be understood by one of ordinary skill in the art that each of the haptics 104 can also comprise only the expandable spreaders 500 or only the 26 expandable protuberances 600 as discrete components 800.
27 [0258] As shown in Figs. 7A, 7B, and 8, the adjustable AIOL 100 can be configured such that 28 a base power of the adjustable AIOL 100 can be adjusted in a first manner (e.g., increasing the 29 base power) by directing or otherwise applying an external energy 302 at a first portion of the haptic 104 made in part of the composite material 200. Moreover, the base power of the 31 adjustable AIOL 100 can be adjusted in a second manner (e.g., decreasing the base power) by 1 directing or otherwise applying additional bursts or pulses of the external energy 302 at a 2 second portion of the same or different haptic 104 made in part of the composite material 200.
3 In some embodiments, the composite material 200 used to make the first portion of the haptic 4 104 can be or exhibit a different color than the composite material 200 used to make the second portion of the haptic 104 as a result of differences in the energy absorbing constituents 6 204 making up the composite materials 200.
7 [0259] Fig. 9A illustrates a top plan view of another embodiment of the adjustable AIOL 100 8 comprising both expandable spreaders 500 and expandable protuberances 600 arranged in a 9 visually perceptible pattern 900. The visually perceptible pattern 900 can allow a clinician or medical professional responsible for post-operatively adjusting the adjustable AIOL 100 to 11 distinguish between the expandable spreaders 500 and the expandable protuberances 600, 12 especially when the expandable spreaders 500 and the expandable protuberances 600 are made 13 from the same composite material 200 having the same color (as shown in Fig. 9A). This can 14 allow the clinician or medical professional to more easily determine where to direct or apply the external energy 302 on the adjustable AIOL 100 in order to adjust an optical parameter of 16 the adjustable AIOL WO.
17 [0260] As shown in Fig. 9A-9C, the visually perceptible pattern 900 can include both a 18 continuous curved segment of the expandable protuberance 600 and spaced-apart branches or 19 fmger-shaped segments of the expandable spreaders 500 extending radially inward from the continuous curved segment. Fig. 9A also illustrates that the branches or finger-shaped 21 segments of the expandable protuberance 600 can be separated from one another by portions 22 of haptic material 902. The haptic material 902 can be the same haptic material used to 23 construct the remainder of the haptic(s) 104_ For example, the visually perceptible pattern 900 24 can be a comb-shaped pattern. In other embodiments, the visually perceptible pattern 900 can be a wave pattern, a chained-triangular pattern, a zig-zag pattern, or a combination thereof.
26 [0261] For example, a clinician or another medical professional can direct or otherwise apply 27 the external energy 302 at the spaced-apart branches or finger-shaped segments to expand the 28 expandable spreaders 500 in order to decrease the base power of the adjustable AIOL 100. The 29 clinician or medical professional can also direct or otherwise apply the external energy 302 at the expandable protuberance 600 shaped as the curved portion positioned radially outward of 1 the spaced-apart branches or finger-shaped segments to expand the expandable protuberance 2 600 in order to increase the base power of the adjustable AIOL 100.
3 [0262] Fig. 9B illustrates a sectional view of the embodiment of the adjustable AIOL 100 4 shown in Fig. 9A taken along cross-section A-A. As shown in Fig. 9B, this section of the haptic 104 can comprise both the expandable spreader 500 and the expandable protuberance 6 600 adhered, formed, or otherwise positioned along the radially inner wall 602. The 7 expandable spreaders 500 can be positioned along the radially innermost portion 700 of the 8 radially inner wall 602 or at a radially innermost end of a channel 502 defined along the 9 radially inner wall 602. The expandable protuberance 600 can be positioned along a radially outermost portion 606 of the radially inner wall 602 of the haptic 104. The expandable 11 protuberance 600 can be positioned underneath or further posterior of the expandable spreader 12 500. Moreover, the adjustable AIOL 100 can be configured such that a void space 608 or gap 13 separates the radially inner wall 602 of the haptic 104 from the outer peripheral surface 142 of 14 the optic portion 102 such that expansion of the expandable spreader 500 does not cause any part of the haptic 104 to substantially impinge on or push up against the outer peripheral 16 surface 142 of the optic portion 102 (thereby preventing the haptic(s) 104 from being pushed 17 against the sides of the capsular bag 304, which can cause deformation of the haptic(s) 104 and 18 affect the volume of the haptic fluid chamber(s) 120).
19 [0263] Fig. 9C illustrates a sectional view of the embodiment of the adjustable AIOL 100 shown in Fig. 9A taken along cross-section B-B. As shown in Fig. 9C, this section of the 21 haptic 104 can comprise only the expandable protuberance 600 adhered, formed, or otherwise 22 positioned along the radially inner wall 602. The expandable protuberance 600 can be 23 positioned along a radially outermost portion 606 of the radially inner wall 602 of the haptic 24 104. The remainder of the radially inner wall 602 can be made of the same haptic material 902 used to construct the rest of the haptic 104.
26 [0264] The visually perceptible pattern 900 can allow a clinician or medical professional to 27 more easily determine where to direct or apply the external energy 302 on the adjustable AIOL
28 100 in order to adjust an optical parameter of the adjustable AIOL 100.
This can be useful 29 when both the expandable spreaders 500 and the expandable protuberances 600 are made of the same composite material 200 having or exhibiting the same color. The clinician or medical 31 professional can direct or otherwise apply the external energy 302 exclusively at the 1 expandable protuberance 600 shaped as the curved portion to expand the expandable 2 protuberance 600 in order to increase the base power of the adjustable AIOL 100. The 3 clinician or medical professional can also direct or otherwise apply the external energy 302 4 exclusively at the branches or finger-shaped portion to expand the expandable spreaders 500 in order to decrease the base power of the adjustable AIOL 100.
6 [0265] One technical problem faced by the applicants is how to integrate the composite 7 material with the rest of the adjustable AIOL without interfering with the optical quality of the 8 lens. One solution discovered by the applicants and disclosed herein is to position or embed 9 the composite material within or along the haptic chamber walls. More specifically, the solution discovered by the applicants is to position or embed the composite material along or 11 within the radially inner wall of the haptic(s).
12 [0266] Fig. 10 illustrates a sectional view of an optic portion 102 of another embodiment of 13 the adjustable AIOL 100 comprising an adhesive layer 1000 made in part of the composite 14 material 200. In some embodiments, the adhesive layer 1000 can comprise the composite material 200 integrated or mixed with the adhesives 148 previously discussed.
In other 16 embodiments, the composite material 200 can be positioned or sandwiched in between layers 17 of the adhesive 148.
18 [0267] The adhesive layer 1000 can be positioned or disposed along the peripheral edge 150 19 of the posterior element 108 (i.e., the top of the raised inner surface 132). Although Fig. 10 illustrates the adhesive layer 1000 as being located along opposing sides of the optic portion 21 102, it should be understood by one of ordinary skill in the art that the adhesive layer 1000 22 extends circumferentially around the entire periphery of the optic portion 102. The adhesive 23 layer 1000 can also be referred to as rotationally symmetric.
24 [0268] In some embodiments, the base power of the adjustable AIOL 100 can be configured to decrease in response to an external energy 302 directed or otherwise applied at the adhesive 26 layer 1000. The adhesive layer 10000 can be configured to expand in response to the external 27 energy 302 directed at the adhesive layer 1000. The external energy 302 can be directed at the 28 entire adhesive layer 1000 surrounding the periphery of the optic portion 102.
29 [0269] Expansion of the adhesive layer 1000 can raise the anterior element 106 and increase the volume of the optic fluid chamber 110. This can cause the anterior element 106 to flatten 31 slightly as the internal fluid pressure within the fluid-filled optic fluid chamber 110 decreases.
1 [0270] In some embodiments, bursts or pulses of external energy 302 (e.g., light energy) 2 directed at the adhesive layer 1000 can result in a decrease in base power of the adjustable 3 AIOL 100 by between about -0.10 D and -0.20 D (e.g., about -0.125 D). For example, pulses 4 of green laser light directed at the adhesive layer 1000 can result in a decrease in the base power of the adjustable AIOL 100 by between about -0.10 D and -0.20 D (e.g., about -0.125 6 D). In some embodiments, the base power of the adjustable AIOL 100 can decrease between 7 about -1.0 D to about -5.0 D (e.g., about -2.0 D) in total in response to bursts or pulses of the 8 external energy 302 directed at the adhesive layer 1000.
9 [0271] Fig. 11 illustrates a perspective view of another embodiment of the adjustable AIOL
100 comprising an adjustable anterior element 1100 having the composite material 200 located 11 or positioned along diametrically opposed peripheral portions of the anterior element 1100. As 12 shown in Fig. 11, the composite material 200 can be shaped or configured as a number of 13 discrete components 800 arranged on opposing peripheral edges of the anterior element 1100.
14 [0272] For example, the composite material 200 can be shaped or configured as a plurality of discrete components 800 lined up along a first peripheral edge 1102 and a second peripheral 16 edge 1104 of the anterior element 1100. The first peripheral edge 1102 can be located 17 diametrically opposed to or separated by about 180 degrees from the second peripheral edge 18 1104. In all such embodiments, the composite material 200 does not extend along the entire 19 circumference or surround the entire periphery of the anterior element 1100.
[0273] In some embodiments, the composite material 200 can be located or adhered in 21 between the anterior optical surface 112 and the anterior inner surface 114. In other 22 embodiments, the composite material 200 can extend out or protrude partly from the anterior 23 optical surface 112. The composite material 200 can be visually perceptible to a clinician or 24 another medical professional when the adjustable AIOL 100 is implanted within an eye of a patient. For example, the composite material 200 can be made in part of an energy absorbing 26 constituent 204 or colorant having or exhibiting a color (e.g., red-color or black-color) that is 27 visually perceptible to the clinician or another medical professional.
28 [0274] The clinician or another medical professional can direct or otherwise apply an external 29 energy 302 to the composite material 200 (for example, to all of the composite material 200 shaped or configured as discrete components 800 along the first peripheral edge 1102 and the 31 second peripheral edge 1104). The composite material 200 can expand in response to this 1 application of external energy 302. This expansion or swelling of the composite material 200 2 can cause the anterior optical surface 112 of the anterior element 1100 to flatten or exhibit a 3 flatter curvature along a rust meridian (referred to as a flat meridian 1106) of the anterior 4 element 1100. The flat meridian 1106 can be substantially perpendicular to another meridian (referred to as a steep meridian 1108) of the anterior element 1100 where the curvature of the 6 anterior element 1100 along this other meridian is substantially unaffected by the expansion of 7 the composite material 200. In this manner, a cylinder or cylindricity is induced on the anterior 8 optical surface 112 of the anterior element 1100. This change in the cylindricity of the anterior 9 element 1100 can persist or remain substantially permanent even after the external energy 302 is no longer directed or applied to the anterior element 1100.
11 [0275] More specifically, in response to the application of the external energy 302, the radius 12 of curvature of the anterior optical surface 112 measured along the flat meridian 1106 can be 13 greater than the radius of curvature of the anterior optical surface 112 measured along the 14 steep meridian 1108. Moreover, in response to the application of the external energy 302, a peripheral thickness of the anterior element 1100 along the flat meridian 1106 can be greater 16 than a peripheral thickness of the anterior element 1100 along the steep meridian 1108_ 17 [0276] In some embodiments, applying or directing the external energy 302 at the composite 18 material 200 can induce the anterior element 1100 to have a cylinder power between about 19 +0.50 D to about +5.0 D (e.g., about +1.50D or about +3.0 D). The cylinder power can be measured along the steep meridian 1108 of the anterior element 1100.
21 [0277] Although Fig. 11 illustrates an adjustable AIOL 100 comprising an adjustable anterior 22 element 1100 having the composite material 200, it is contemplated by this disclosure that the 23 adjustable AIOL 100 can also comprise an adjustable posterior element having the composite 24 material 200. For example, the composite material 200 can be located or positioned along diametrically opposed peripheral portions of the posterior element. The composite material 26 200 can be shaped or configured as a number of discrete components 800 arranged on 27 opposing peripheral edges of the posterior element.
28 [0278] In some embodiments, the composite material 200 can be located or adhered in 29 between the posterior optical surface 116 and the posterior inner surface 118 (see, for example, Figs. 1B and 1C). In other embodiments, the composite material 200 can extend out or 31 protrude partly from the posterior optical surface 116. The composite material 200 can be 1 visually perceptible to a clinician or another medical professional when the adjustable AIOL
2 100 is implanted within an eye of a patient.
3 [0279] The clinician or another medical professional can direct or otherwise apply an external 4 energy 302 to the composite material 200 making up part of the peripheral edges of the posterior element. The composite material 200 can expand in response to this application of 6 external energy 302. This expansion or swelling of the composite material 200 can cause the 7 posterior optical surface 116 to flatten or exhibit a flatter curvature along a flat meridian of the 8 posterior element. The flat meridian can be substantially perpendicular to a steep meridian of 9 the posterior element where the curvature of the posterior element along the steep meridian is substantially unaffected by the expansion of the composite material 200. In this manner, a 11 cylinder or cylindricity is induced on the posterior optical surface 116 of the posterior element.
12 This change in the cylindricity of the posterior element can persist or remain substantially 13 permanent even after the external energy 302 is no longer directed or applied to the posterior 14 element.
[0280] More specifically, in response to the application of the external energy 302, the radius 16 of curvature of the posterior optical surface 116 measured along the flat meridian can be 17 greater than the radius of curvature of the posterior optical surface 116 measured along the 18 steep meridian. Moreover, in response to the application of the external energy 302, a 19 peripheral thickness of the posterior element along the flat meridian can be greater than a peripheral thickness of the posterior element along the steep meridian.
21 [0281] In some embodiments, applying or directing the external energy 302 at the composite 22 material 200 can induce the posterior element to have a cylinder power between about +0.5 D
23 to about -1-5.0 D (e.g., about +1.5D or about +3.0 D). The cylinder power can be measured 24 along the steep meridian of the posterior element.
[0282] One technical problem faced by the applicants is how to induce cylindricity or cylinder 26 in an accommodating intraocular lens without interfering with the optical quality of the lens.
27 One solution discovered by the applicants and disclosed herein is to position or embed the 28 composite material along or within the peripheral edges of an optical element (e.g., the anterior 29 element, the posterior element, or a combination thereof). More specifically, the solution discovered by the applicants is to position or embed the composite material along or within 1 part of two diametrically opposed peripheral edges of at least one of the anterior element and 2 the posterior element.
3 [0283] Disclosed herein is an intraocular lens, comprising: an optic portion; a peripheral 4 portion coupled to the optic portion; wherein at least one of the optic portion and the peripheral portion is made in part of a composite material comprising an energy absorbing 6 constituent and a plurality of expandable components, and wherein a base power of the optic 7 portion is configured to change in response to an external energy directed at the composite 8 material.
9 [0284] The intraocular lens as disclosed herein, wherein the base power of the optic portion is configured to change in response to the external energy directed at the composite material 11 when the intraocular lens is implanted within an eye of a subject.
12 [0285] The intraocular lens as disclosed herein, wherein the expandable components are 13 expandable microspheres, wherein each of the expandable microspheres comprises a blowing 14 agent contained within a thermoplastic shell.
[0286] The intraocular lens as disclosed herein, wherein the blowing agent is a branched-chain 16 hydrocarbon.
17 [0287] The intraocular lens as disclosed herein, wherein the branched-chain hydrocarbon is 18 isopentane.
19 [0288] The intraocular lens as disclosed herein, wherein a thickness of the thermoplastic shell is configured to change in response to the external energy directed at the composite material.
21 [0289] The intraocular lens as disclosed herein, wherein the thermoplastic shell is made in part 22 of an acrylonitrile copolymer.
23 [0290] The intraocular lens as disclosed herein, wherein a diameter of at least one of the 24 expandable micmspheres is configured to increase between about 2X to about 4X in response to the external energy directed at the composite material.
26 [0291] The intraocular lens as disclosed herein, wherein a volume of at least one of the 27 expandable components is configured to expand between about 10X to 50X
in response to the 28 external energy directed at the composite material.
29 [0292] The intraocular lens as disclosed herein, wherein the expandable components comprise between about 5% to about 15% by weight of the composite material.
1 [0293] The intraocular lens as disclosed herein, wherein the expandable components comprise 2 about 10% by weight of the composite material.
3 [0294] The intraocular lens as disclosed herein wherein the energy absorbing constituent is an 4 energy absorbing colorant.
[0295] The intraocular lens as disclosed herein, wherein a color of the energy absorbing 6 colorant is visually perceptible to a clinician when the intraocular lens is implanted within an 7 eye.
8 [0296] The intraocular lens as disclosed herein, wherein the energy absorbing colorant is a 9 dye.
[0297] The intraocular lens as disclosed herein, wherein the dye is an azo dye.
11 [0298] The intraocular lens as disclosed herein, wherein the dye is a Disperse Red 1 dye.
12 [0299] The intraocular lens as disclosed herein, wherein the energy absorbing colorant is a 13 pigment.
14 [0300] The intraocular lens as disclosed herein, wherein the pigment is graphitized carbon black.
16 [0.301] The intraocular lens as disclosed herein, wherein the at least one of the optic portion 17 and the peripheral portion is made in part of a first composite material and a second composite 18 material, wherein the first composite material comprises a first energy absorbing colorant and 19 the second composite material comprises a second energy absorbing colorant, wherein a color of the first energy absorbing colorant is different from a color of the second energy absorbing 21 colorant.
22 [0302] The intraocular lens as disclosed herein, wherein the energy absorbing constituent 23 comprises between about 0.025% to about 1.00% by weight of the composite material.
24 [0303] The intraocular lens as disclosed herein, wherein at least one of the optic portion and the peripheral portion is made in part of a cross-linked copolymer comprising a copolymer 26 blend, and wherein the composite material is made in part of the copolymer blend.
27 [0304] The intraocular lens as disclosed herein, wherein the copolymer blend comprises an 28 allcyl acrylate, a fluoro-alkyl acrylate, and a phenyl-alkyl acrylate.
29 [0305] The intraocular lens as disclosed herein, wherein the composite material further comprises at least one of reactive acrylic monomer diluents, a photoinitiator, and a thermal 31 initiator.
1 [0306] The intraocular lens as disclosed herein, wherein the composite material adheres to the 2 cross-linked copolymer at a location within the at least one of the optic portion and the 3 peripheral portion, and wherein the composite material remains substantially fixed at the 4 location.
[0307] The intraocular lens as disclosed herein, wherein the base power of the optic portion is 6 configured to change between about 0.05 D to about 0.5 D in response to pulses of the 7 external energy directed at the composite material.
8 [0308] The intraocular lens as disclosed herein, wherein the base power of the optic portion is 9 configured to change by up to -5.0D in total.
[0309] The intraocular lens as disclosed herein, wherein the external energy is light energy.
11 [0310] The intraocular lens as disclosed herein, wherein the light energy is a laser light.
12 [0311] The intraocular lens as disclosed herein, wherein the laser light has a wavelength 13 between about 488 nnt to about 650 nm.
14 [0312] The intraocular lens as disclosed herein, wherein the laser light is a green laser light.
[0313] The intraocular lens as disclosed herein, wherein the green laser light has a wavelength 16 of about 532 um.
17 [0314] The intraocular lens as disclosed herein, wherein the optic portion is made in part of 18 the composite material, and wherein the base power is configured to change in response to the 19 external energy directed at the optic portion.
[0315] The intraocular lens as disclosed herein, wherein the peripheral portion is made in part 21 of the composite material, and wherein the base power of the optic portion is configured to 22 change in response to the external energy directed at the peripheral portion.
23 [0316] The intraocular lens as disclosed herein, wherein the optic portion is made in part of 24 the composite material, and wherein a cylindricity of an optical surface of the optic portion is configured to change in response to the external energy directed at the optic portion.
26 [0317] The intraocular lens as disclosed herein, wherein the change in the cylindricity of the 27 optic portion is a persistent change.
28 [0318] The intraocular lens as disclosed herein, wherein the change in the base power is a 29 persistent change.
1 [0319] The intraocular lens as disclosed herein, wherein the optic portion comprises an 2 anterior element having an anterior optical surface and a posterior element having a posterior 3 optical surface.
4 [0320] The intraocular lens as disclosed herein, wherein the composite material is located along a first peripheral edge of the anterior element and along a second peripheral edge of the 6 anterior element diametrically opposed to the first peripheral edge, and wherein the 7 cylindricity of the anterior optical surface is configured to change in response to the external 8 energy directed at the first peripheral edge and the second peripheral edge.
9 [0321] The intraocular lens as disclosed herein, wherein the composite material is located along a first peripheral edge of the posterior element and along a second peripheral edge of the 11 posterior element diametrically opposed to the first peripheral edge, and wherein the 12 cylindricity of the posterior optical surface is configured to change in response to the external 13 energy directed at the first peripheral edge and the second peripheral edge.
14 [0322] The intraocular lens as disclosed herein, wherein the optic portion comprises an anterior element, a posterior element, and a fluid-filled optic chamber defined therebetween, 16 and wherein the anterior element is bonded or adhered circumferentially to the posterior 17 element by an adhesive layer and wherein the adhesive layer comprises the composite 18 material.
19 [0323] The intraocular lens as disclosed herein, wherein the base power is configured to decrease in response to an expansion of the adhesive layer as a result of the external energy 21 directed at the composite material within the adhesive layer.
22 [0324] The intraocular lens as disclosed herein, wherein the optic portion comprises a fluid-23 filled optic chamber and the peripheral portion comprises at least one haptic comprising a 24 fluid-filled haptic fluid chamber in fluid communication with the optic chamber.
[0325] The intraocular lens as disclosed herein, wherein the base power is configured to 26 change in response to fluid displacement between the optic chamber and the haptic fluid 27 chamber as a result of the external energy directed at the composite material.
28 [0326] The intraocular lens as disclosed herein, wherein the base power is configured to 29 change in response to a change in a volume of the haptic fluid chamber as a result of the external energy directed at the composite material.
1 [0327] The intraocular lens as disclosed herein, wherein the base power is configured to 2 change in response to an interaction between the haptic and a capsular environment 3 surrounding the intraocular lens when the intraocular lens is implanted within an eye.
4 [0328] The intraocular lens as disclosed herein, wherein the composite material is configured as a spacer extending radially from a haptic chamber wall, wherein the spacer is configured to 6 expand in response to the external energy directed at the spacer, and wherein expansion of the 7 spacer decreases a volume of the haptic fluid chamber by pushing the haptic against the 8 capsular environment.
9 [0329] The intraocular lens as disclosed herein, wherein the composite material is located partly within a haptic chamber wall surrounding the haptic fluid chamber.
11 [0330] The intraocular lens as disclosed herein, wherein the composite material is located at 12 least partially within a channel formed along a radially inner wall of the haptic, wherein a 13 volume of the haptic fluid chamber is configured to expand in response to the external energy 14 directed at the composite material.
[0331] The intraocular lens as disclosed herein, wherein the composite material is located at 16 least partly along a radially outermost portion of a radially inner wall of the haptic, wherein a 17 volume of the haptic fluid chamber is configured to decrease in response to the external energy 18 directed at the composite material.
19 [0332] The intraocular lens as disclosed herein, wherein the composite material is configured to expand into the haptic fluid chamber in response to the external energy directed at the 21 composite material.
22 [0333] The intraocular lens as disclosed herein, wherein the energy absorbing constituent is 23 configured to transfer thermal energy to the plurality of expandable components in response to 24 the external energy directed at the composite material.
[0334] Also disclosed herein is an accommodating intraocular lens, comprising:
an optic 26 portion; and a haptic coupled to the optic portion, wherein the haptic comprises a first haptic 27 portion and a second haptic portion, wherein the first haptic portion is made in part of a 28 composite material comprising an energy absorbing constituent and a plurality of expandable 29 components, wherein the second haptic portion is made in part of the composite material, wherein a base power of the optic portion is configured to increase in response to an external 1 energy directed at the first haptic portion, and wherein the base power of the optic portion is 2 configured to decrease in response to the external energy directed at the second haptic portion.
3 [0335] The accommodating intraocular lens as disclosed herein, wherein the optic portion 4 comprises a fluid-filled optic fluid chamber and the haptic comprises a fluid-filled haptic fluid chamber in fluid communication with the optic fluid chamber.
6 [0336] The accommodating intraocular lens as disclosed herein, wherein the base power of the 7 optic portion is configured to increase in response to the external energy directed at the first 8 haptic portion as a result of fluid flowing from the haptic fluid chamber to the optic fluid 9 chamber.
[0337] The accommodating intraocular lens as disclosed herein, wherein the base power of the 11 optic portion is configured to decrease in response to the external energy directed at the second 12 haptic portion as a result of fluid flowing from the optic fluid chamber to the haptic fluid 13 chamber.
14 [0338] The accommodating intraocular lens as disclosed herein, wherein at least one of the first haptic portion and the second haptic portion is located partly within a haptic chamber wall 16 surrounding the haptic fluid chamber.
17 [0339] The accommodating intraocular lens as disclosed herein, wherein the first haptic 18 portion is made in part of a first composite material, wherein the second haptic portion is made 19 in part of a second composite material, wherein the first composite material comprises a first energy absorbing constituent, wherein the second composite material comprises a second 21 energy absorbing constituent, and wherein a composition of the first energy absorbing 22 constituent is different from a composition of the second energy absorbing constituent.
23 [0340] The accommodating intraocular lens as disclosed herein, wherein the first haptic 24 portion is made in part of a first composite material, wherein the second haptic portion is made in part of a second composite material, wherein the first composite material comprises a first 26 energy absorbing constituent, wherein the second composite material comprises a second 27 energy absorbing constituent, and wherein a composition of the first energy absorbing 28 constituent is the same as a composition of the second energy absorbing constituent.
29 [0341] The accommodating intraocular lens as disclosed herein, wherein the first energy absorbing constituent has a first color and wherein the second energy absorbing constituent has 31 a second color different from the first color.
1 [0342] The accommodating intraocular lens as disclosed herein, wherein the first haptic 2 portion is radially offset from the second haptic portion.
3 [0343] The accommodating intraocular lens as disclosed herein, wherein at least one of the 4 first haptic portion and the second haptic portion is oriented in a pattern such that a location of the at least one of the first haptic portion and the second haptic portion along the haptic is 6 visually perceptible to a clinician.
7 [0344] Also disclosed herein is a method of adjusting an accommodating intraocular lens, 8 comprising: adjusting a base power of the accommodating intraocular lens by directing an 9 external energy at a composite material within at least one of an optic portion and a peripheral portion of the accommodating intraocular lens, wherein the composite material comprises an 11 energy absorbing constituent and a plurality of expandable components.
12 [0345] The method as disclosed herein, further comprising adjusting the base power of the 13 accommodating intraocular lens when the accommodating intraocular lens is implanted within 14 an eye of a subject.
[0346] The method as disclosed herein, further comprising adjusting the cylindricity of an 16 optical surface of an optic portion the accommodating intraocular lens by directing an external 17 energy at the composite material arranged at diametrically opposed peripheral edges of the 18 optic portion.
19 [0347] The method as disclosed herein, further comprising directing the external energy at the composite material to energize the energy absorbing constituent to cause thermal energy to be 21 transferred to the plurality of expandable components.
22 [0348] The method as disclosed herein, wherein the plurality of expandable components are 23 expandable thermoplastic microspheres, wherein directing the external energy at the composite 24 material expands the thermoplastic microspheres.
[0349] The method as disclosed herein, wherein the external energy is light energy.
26 [0350] The method as disclosed herein, wherein the light energy is a laser light having a 27 wavelength between about 488 nm to about 650 nm.
28 [0351] The method as disclosed herein, further comprising adjusting the base power of the 29 optic portion between about 0.05 D to about - 0.5 D by directing pulses of the external energy at the composite material.
1 [0352] The method as disclosed herein, wherein the optic portion comprises a fluid-filled optic 2 chamber and the peripheral portion comprises at least one haptic comprising a fluid-filled 3 haptic fluid chamber in fluid communication with the optic chamber, wherein the method 4 further comprises directing the external energy at the composite material to displace fluid between the optic chamber and the haptic fluid chamber.
6 [0353] The method as disclosed herein, further comprising adjusting the base power of the 7 accommodating intraocular lens by directing the external energy at the composite material to 8 change a volume of the haptic fluid chamber.
9 [0354] The method as disclosed herein, further comprising adjusting the base power of the accommodating intraocular lens by directing the external energy at the composite material to 11 cause the peripheral portion to interact with a capsular environment surrounding the 12 accommodating intraocular lens when the accommodating intraocular lens is implanted within 13 an eye.
14 [0355] The method as disclosed herein, further comprising adjusting the base power of the accommodating intraocular lens by directing the external energy at the composite material to 16 change a volume of the optic fluid chamber.
17 [0356] The method as disclosed herein, wherein at least one of the optic portion and the 18 peripheral portion is made in part of a cross-linked copolymer comprising a copolymer blend, 19 and wherein the composite material is made in part of the copolymer blend.
[0357] A number of embodiments have been described. Nevertheless, it will be understood by 21 one of ordinary skill in the art that various changes and modifications can be made to this 22 disclosure without departing from the spirit and scope of the embodiments. Elements of 23 systems, devices, apparatus, and methods shown with any embodiment are exemplary for the 24 specific embodiment and can be used in combination or otherwise on other embodiments within this disclosure. For example, the steps of any methods depicted in the figures or 26 described in this disclosure do not require the particular order or sequential order shown or 27 described to achieve the desired results. In addition, other steps operations may be provided, or 28 steps or operations may be eliminated or omitted from the described methods or processes to 29 achieve the desired results. Moreover, any components or parts of any apparatus or systems described in this disclosure or depicted in the figures may be removed, eliminated, or omitted 31 to achieve the desired results. In addition, certain components or parts of the systems, devices, 1 or apparatus shown or described herein have been omitted for the sake of succinctness and 2 clarity.
3 [0358] Accordingly, other embodiments are within the scope of the following claims and the 4 specification and/or drawings may be regarded in an illustrative rather than a restrictive sense.
[0359] Each of the individual variations or embodiments described and illustrated herein has 6 discrete components and features which may be readily separated from or combined with the 7 features of any of the other variations or embodiments. Modifications may be made to adapt a 8 particular situation, material, composition of matter, process, process act(s) or step(s) to the 9 objective(s), spirit or scope of the present invention.
[0360] Methods recited herein may be carried out in any order of the recited events that is 11 logically possible, as well as the recited order of events. Moreover, additional steps or 12 operations may be provided or steps or operations may be eliminated to achieve the desired 13 result.
14 [0361] Furthermore, where a range of values is provided, every intervening value between the upper and lower limit of that range and any other stated or intervening value in that stated 16 range is encompassed within the invention. Also, any optional feature of the inventive 17 variations described may be set forth and claimed independently, or in combination with any 18 one or more of the features described herein. For example, a description of a range from 1 to 5 19 should be considered to have disclosed subranges such as from 1 to 3, from 1 to 4, from 2 to 4, from 2 to 5, from 3 to 5, etc. as well as individual numbers within that range, for example 1.5, 21 2.5, etc. and any whole or partial increments therebetween.
22 [0362] All existing subject matter mentioned herein (e.g., publications, patents, patent 23 applications) is incorporated by reference herein in its entirety except insofar as the subject 24 matter may conflict with that of the present invention (in which case what is present herein shall prevail). The referenced items are provided solely for their disclosure prior to the filing 26 date of the present application. Nothing herein is to be construed as an admission that the 27 present invention is not entitled to antedate such material by virtue of prior invention.
28 [0363] Reference to a singular item, includes the possibility that there are plural of the same 29 items present. More specifically, as used herein and in the appended claims, the singular forms "a," "an," "said" and "the" include plural referents unless the context clearly dictates 31 otherwise. It is further noted that the claims may be drafted to exclude any optional element.
1 As such, this statement is intended to serve as antecedent basis for use of such exclusive 2 terminology as "solely," "only" and the like in connection with the recitation of claim 3 elements, or use of a "negative" limitation. Unless defined otherwise, all technical and 4 scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.
6 [0364] Reference to the phrase "at least one of', when such phrase modifies a plurality of 7 items or components (or an enumerated list of items or components) means any combination 8 of one or more of those items or components. For example, the phrase "at least one of A, B, 9 and C" means: (i) A; (ii) B; (iii) C; (iv) A, B, and C; (v) A and B; (vi) B and C; or (vii) A and C
11 [0365] In understanding the scope of the present disclosure, the term "comprising" and its 12 derivatives, as used herein, are intended to be open-ended terms that specify the presence of 13 the stated features, elements, components, groups, integers, and/or steps, but do not exclude 14 the presence of other unstated features, elements, components, groups, integers and/or steps.
The foregoing also applies to words having similar meanings such as the terms, "including", 16 "having" and their derivatives. Also, the terms "part," "section,"
"portion," "member"
17 "element," or "component" when used in the singular can have the dual meaning of a single 18 part or a plurality of parts. As used herein, the following directional terms "forward, rearward, 19 above, downward, vertical, horizontal, below, transverse, laterally, and vertically" as well as any other similar directional terms refer to those positions of a device or piece of equipment or 21 those directions of the device or piece of equipment being translated or moved.
22 [0366] Finally, terms of degree such as "substantially", "about" and "approximately" as used 23 herein mean the specified value or the specified value and a reasonable amount of deviation 24 from the specified value (e.g., a deviation of up to - 0.1%, - 1%, -5%, or - 10%, as such variations are appropriate) such that the end result is not significantly or materially changed.
26 For example, "about 1.0 cm" can be interpreted to mean "1.0 cm" or between "0.9 cm and 1.1 27 cm." When terms of degree such as "about" or "approximately" are used to refer to numbers or 28 values that are part of a range, the term can be used to modify both the minimum and 29 maximum numbers or values.
[0367] This disclosure is not intended to be limited to the scope of the particular forms set 31 forth, but is intended to cover alternatives, modifications, and equivalents of the variations or 1 embodiments described herein. Further, the scope of the disclosure fully encompasses other 2 variations or embodiments that may become obvious to those skilled in the art in view of this 3 disclosure.
Claims
2 We claim:
3 1. An intraocular lens, comprising:
4 an optic portion;
a peripheral portion coupled to the optic portion;
6 wherein at least one of the optic portion and the peripheral portion is made in 7 part of a composite material comprising an energy absorbing constituent 8 and a plurality of expandable components, and 9 wherein a base power of the optic portion is configured to change in response to an external energy directed at the composite material.
11 2. The intraocular lens of claim 1, wherein the expandable components are expandable 12 microspheres, wherein each of the expandable microspheres comprises a blowing agent 13 contained within a thermoplastic shell.
14 3. The intraocular lens of claim 2, wherein a diameter of at least one of the expandable microspheres is configured to increase between about 2X to about 4X in response to 16 the external energy directed at the composite material.
17 4. The intraocular lens of claim 1, wherein the energy absorbing constituent is an energy 18 absorbing colorant.
19 5. The intraocular lens of claim 4, wherein the energy absorbing colorant is an azo dye.
6. The intraocular lens of claim 4, wherein the energy absorbing colorant is graphitized 21 cathon black.
22 7. The intraocular lens of claim 4, wherein the at least one of the optic portion and the 23 peripheral portion is made in part of a first composite material and a second composite 24 material, wherein the first composite material comprises a first energy absorbing colorant and the second composite material comprises a second energy absorbing 26 colorant, wherein a color of the first energy absorbing colorant is different from a color 27 of the second energy absorbing colorant.
28 8. The intraocular lens of claim 1, wherein at least one of the optic portion and the peripheral 29 portion is made in part of a cross-linked copolymer comprising a copolymer blend, and wherein the composite material is made in part of the copolymer blend.
1 9. The intraocular lens of claim 8, wherein the copolymer blend comprises an alkyl acrylate, a 2 fluoro-alkyl acrylate, and a phenyl-alkyl acrylate.
3 10. The intraocular lens of claim 1, wherein the base power of the optic portion is configured 4 to change between about - 0.05 D to about -10.5 D in response to a pulse of the external energy directed at the composite material.
6 11. The intraocular lens of claim 1, wherein the base power of the optic portion is configured 7 to change by up to -5.0D in total.
8 12. The intraocular lens of claim 1, wherein the external energy is laser light having a 9 wavelength between about 488 nm to about 650 nm.
13. The intraocular lens of claim 1, wherein the optic portion is made in part of the composite 11 material, and wherein a cylindricity of an optical surface of the optic portion is 12 configured to change in response to the external energy directed at the optic portion.
13 14. The intraocular lens of claim 1, wherein the optic portion comprises an anterior element 14 having an anterior optical surface and a posterior element having a posterior optical surface.
16 15. The intraocular lens of claim 14, wherein the composite material is located along a first 17 peripheral edge of the anterior element and along a second peripheral edge of the 18 anterior element diametrically opposed to the first peripheral edge, and wherein the 19 cylindricity of the anterior optical surface is configured to change in response to the external energy directed at the first peripheral edge and the second peripheral edge.
21 16. The intraocular lens of claim 14, wherein the composite material is located along a first 22 peripheral edge of the posterior element and along a second peripheral edge of the 23 posterior element diametrically opposed to the first peripheral edge, and wherein the 24 cylindricity of the posterior optical surface is configured to change in response to the external energy directed at the first peripheral edge and the second peripheral edge.
26 17. The intraocular lens of claim 1, wherein the optic portion comprises an anterior element, a 27 posterior element, and a fluid-filled optic chamber defined therebetween, and wherein 28 the anterior element is bonded or adhered circumferentially to the posterior element by 29 an adhesive layer and wherein the adhesive layer comprises the composite material.
1 18. The intraocular lens of claim 1, wherein the optic portion comprises a fluid-filled optic 2 chamber and the peripheral portion comprises at least one haptic comprising a fluid-3 filled haptic fluid chamber in fluid communication with the optic chamber.
4 19. The intraocular lens of claim 18, wherein the base power is configured to change in response to fluid displacement between the optic chamber and the haptic fluid chamber 6 as a result of the external energy directed at the composite material.
7 20. The intraocular lens of claim 18, wherein the base power is configured to change in 8 response to a change in a volume of the haptic fluid chamber as a result of the external 9 energy directed at the composite material.
21. The intraocular lens of claim 18, wherein the composite material is configured as a spacer 11 extending radially from a haptic chamber wall, wherein the spacer is configured to 12 expand in response to the external energy directed at the spacer, and wherein expansion 13 of the spacer decreases a volume of the haptic fluid chamber by pushing the haptic 14 against a capsular environment surrounding the lens.
22. The intraocular lens of claim 18, wherein the composite material is located partly within a 16 haptic chamber wall surrounding the haptic fluid chamber.
17 23. The intraocular lens of claim 18, wherein the composite material is located at least partially 18 within a channel formed along a radially inner wall of the haptic, wherein a volume of 19 the haptic fluid chamber is configured to expand in response to the external energy directed at the composite material.
21 24. The intraocular lens of claim 18, wherein the composite material is located at least partly 22 along a radially outermost portion of a radially inner wall of the haptic, wherein a 23 volume of the haptic fluid chamber is configured to decrease in response to the external 24 energy directed at the composite material.
25. The intraocular lens of claim 24, wherein the composite material is configured to expand 26 into the haptic fluid chamber in response to the external energy directed at the 27 composite material.
28 26. An accommodating intraocular lens, comprising:
29 an optic portion; and a haptic coupled to the optic portion, wherein the haptic comprises a first haptic portion 31 and a second haptic portion, 1 wherein the first haptic portion is made in part of a composite material 2 comprising an energy absorbing constituent and a plurality of expandable 3 components, 4 wherein the second haptic portion is made in part of the composite material, wherein a base power of the optic portion is configured to increase in response 6 to an external energy directed at the first haptic portion, and 7 wherein the base power of the optic portion is configured to decrease in 8 response to the external energy directed at the second haptic portion.
9 27. The accommodating intraocular lens of claim 26, wherein the optic portion comprises a fluid-filled optic fluid chamber and the haptic comprises a fluid-filled haptic fluid 11 chamber in fluid communication with the optic fluid chamber.
12 28. The accommodating intraocular lens of claim 27, wherein the base power of the optic 13 portion is configured to increase in response to the external energy directed at the first 14 haptic portion as a result of fluid flowing from the haptic fluid chamber to the optic fluid chamber.
16 29. The accommodating intraocular lens of claim 27, wherein the base power of the optic 17 portion is configured to decrease in response to the external energy directed at the 18 second haptic portion as a result of fluid flowing from the optic fluid chamber to the 19 haptic fluid chamber.
30. The accommodating intraocular lens of claim 26, wherein the first haptic portion is made 21 in part of a first composite material, wherein the second haptic portion is made in part 22 of a second composite material, wherein the first composite material comprises a first 23 energy absorbing constituent, wherein the second composite material comprises a 24 second energy absorbing constituent, and wherein a composition of the first energy absorbing constituent is different from a composition of the second energy absorbing 26 constituent.
27 31. The accommodating intraocular lens of claim 26, wherein the first haptic portion is radially 28 offset from the second haptic portion.
29 32. A method of adjusting an accommodating intraocular lens, comprising:
1 adjusting a base power of the accommodating intraocular lens by directing an external 2 energy at a composite material within at least one of an optic portion and a 3 peripheral portion of the accommodating intraocular lens, 4 wherein the composite material comprises an energy absorbing constituent and a plurality of expandable components.
6 33. The method of claim 32, further comprising adjusting the base power of the 7 accommodating intraocular lens when the accommodating intraocular lens is implanted 8 within an eye of a subject.
9 34. The method of claim 32, further comprising adjusting the cylindricity of an optical surface of an optic portion the accommodating intraocular lens by directing an external energy 11 at the composite material arranged at diametrically opposed peripheral edges of the 12 optic portion.
13 35. The method of claim 32, wherein the external energy is a laser light having a wavelength 14 between about 488 fun to about 650 nm 36. The method of claim 32, further comprising adjusting the base power of the optic portion 16 between about 0Ø5 D to about +Pi D by directing a pulse of the external energy at 17 the composite material.
18 37. The method of claim 32, wherein the optic portion comprises a fluid-filled optic chamber 19 and the peripheral portion comprises at least one haptic comprising a fluid-filled haptic fluid chamber in fluid communication with the optic chamber, wherein the method 21 further comprises directing the external energy at the composite material to displace 22 fluid between the optic chamber and the haptic fluid chamber.
23 38. The method of claim 32, further comprising adjusting the base power of the 24 accommodating intraocular lens by directing the external energy at the composite material to change a volume of the haptic fluid chamber.
26 39. The method of claim 32, further comprising adjusting the base power of the 27 accommodating intraocular lens by directing the external energy at the composite 28 material to change a volume of the optic fluid chamber.
3 1. An intraocular lens, comprising:
4 an optic portion;
a peripheral portion coupled to the optic portion;
6 wherein at least one of the optic portion and the peripheral portion is made in 7 part of a composite material comprising an energy absorbing constituent 8 and a plurality of expandable components, and 9 wherein a base power of the optic portion is configured to change in response to an external energy directed at the composite material.
11 2. The intraocular lens of claim 1, wherein the expandable components are expandable 12 microspheres, wherein each of the expandable microspheres comprises a blowing agent 13 contained within a thermoplastic shell.
14 3. The intraocular lens of claim 2, wherein a diameter of at least one of the expandable microspheres is configured to increase between about 2X to about 4X in response to 16 the external energy directed at the composite material.
17 4. The intraocular lens of claim 1, wherein the energy absorbing constituent is an energy 18 absorbing colorant.
19 5. The intraocular lens of claim 4, wherein the energy absorbing colorant is an azo dye.
6. The intraocular lens of claim 4, wherein the energy absorbing colorant is graphitized 21 cathon black.
22 7. The intraocular lens of claim 4, wherein the at least one of the optic portion and the 23 peripheral portion is made in part of a first composite material and a second composite 24 material, wherein the first composite material comprises a first energy absorbing colorant and the second composite material comprises a second energy absorbing 26 colorant, wherein a color of the first energy absorbing colorant is different from a color 27 of the second energy absorbing colorant.
28 8. The intraocular lens of claim 1, wherein at least one of the optic portion and the peripheral 29 portion is made in part of a cross-linked copolymer comprising a copolymer blend, and wherein the composite material is made in part of the copolymer blend.
1 9. The intraocular lens of claim 8, wherein the copolymer blend comprises an alkyl acrylate, a 2 fluoro-alkyl acrylate, and a phenyl-alkyl acrylate.
3 10. The intraocular lens of claim 1, wherein the base power of the optic portion is configured 4 to change between about - 0.05 D to about -10.5 D in response to a pulse of the external energy directed at the composite material.
6 11. The intraocular lens of claim 1, wherein the base power of the optic portion is configured 7 to change by up to -5.0D in total.
8 12. The intraocular lens of claim 1, wherein the external energy is laser light having a 9 wavelength between about 488 nm to about 650 nm.
13. The intraocular lens of claim 1, wherein the optic portion is made in part of the composite 11 material, and wherein a cylindricity of an optical surface of the optic portion is 12 configured to change in response to the external energy directed at the optic portion.
13 14. The intraocular lens of claim 1, wherein the optic portion comprises an anterior element 14 having an anterior optical surface and a posterior element having a posterior optical surface.
16 15. The intraocular lens of claim 14, wherein the composite material is located along a first 17 peripheral edge of the anterior element and along a second peripheral edge of the 18 anterior element diametrically opposed to the first peripheral edge, and wherein the 19 cylindricity of the anterior optical surface is configured to change in response to the external energy directed at the first peripheral edge and the second peripheral edge.
21 16. The intraocular lens of claim 14, wherein the composite material is located along a first 22 peripheral edge of the posterior element and along a second peripheral edge of the 23 posterior element diametrically opposed to the first peripheral edge, and wherein the 24 cylindricity of the posterior optical surface is configured to change in response to the external energy directed at the first peripheral edge and the second peripheral edge.
26 17. The intraocular lens of claim 1, wherein the optic portion comprises an anterior element, a 27 posterior element, and a fluid-filled optic chamber defined therebetween, and wherein 28 the anterior element is bonded or adhered circumferentially to the posterior element by 29 an adhesive layer and wherein the adhesive layer comprises the composite material.
1 18. The intraocular lens of claim 1, wherein the optic portion comprises a fluid-filled optic 2 chamber and the peripheral portion comprises at least one haptic comprising a fluid-3 filled haptic fluid chamber in fluid communication with the optic chamber.
4 19. The intraocular lens of claim 18, wherein the base power is configured to change in response to fluid displacement between the optic chamber and the haptic fluid chamber 6 as a result of the external energy directed at the composite material.
7 20. The intraocular lens of claim 18, wherein the base power is configured to change in 8 response to a change in a volume of the haptic fluid chamber as a result of the external 9 energy directed at the composite material.
21. The intraocular lens of claim 18, wherein the composite material is configured as a spacer 11 extending radially from a haptic chamber wall, wherein the spacer is configured to 12 expand in response to the external energy directed at the spacer, and wherein expansion 13 of the spacer decreases a volume of the haptic fluid chamber by pushing the haptic 14 against a capsular environment surrounding the lens.
22. The intraocular lens of claim 18, wherein the composite material is located partly within a 16 haptic chamber wall surrounding the haptic fluid chamber.
17 23. The intraocular lens of claim 18, wherein the composite material is located at least partially 18 within a channel formed along a radially inner wall of the haptic, wherein a volume of 19 the haptic fluid chamber is configured to expand in response to the external energy directed at the composite material.
21 24. The intraocular lens of claim 18, wherein the composite material is located at least partly 22 along a radially outermost portion of a radially inner wall of the haptic, wherein a 23 volume of the haptic fluid chamber is configured to decrease in response to the external 24 energy directed at the composite material.
25. The intraocular lens of claim 24, wherein the composite material is configured to expand 26 into the haptic fluid chamber in response to the external energy directed at the 27 composite material.
28 26. An accommodating intraocular lens, comprising:
29 an optic portion; and a haptic coupled to the optic portion, wherein the haptic comprises a first haptic portion 31 and a second haptic portion, 1 wherein the first haptic portion is made in part of a composite material 2 comprising an energy absorbing constituent and a plurality of expandable 3 components, 4 wherein the second haptic portion is made in part of the composite material, wherein a base power of the optic portion is configured to increase in response 6 to an external energy directed at the first haptic portion, and 7 wherein the base power of the optic portion is configured to decrease in 8 response to the external energy directed at the second haptic portion.
9 27. The accommodating intraocular lens of claim 26, wherein the optic portion comprises a fluid-filled optic fluid chamber and the haptic comprises a fluid-filled haptic fluid 11 chamber in fluid communication with the optic fluid chamber.
12 28. The accommodating intraocular lens of claim 27, wherein the base power of the optic 13 portion is configured to increase in response to the external energy directed at the first 14 haptic portion as a result of fluid flowing from the haptic fluid chamber to the optic fluid chamber.
16 29. The accommodating intraocular lens of claim 27, wherein the base power of the optic 17 portion is configured to decrease in response to the external energy directed at the 18 second haptic portion as a result of fluid flowing from the optic fluid chamber to the 19 haptic fluid chamber.
30. The accommodating intraocular lens of claim 26, wherein the first haptic portion is made 21 in part of a first composite material, wherein the second haptic portion is made in part 22 of a second composite material, wherein the first composite material comprises a first 23 energy absorbing constituent, wherein the second composite material comprises a 24 second energy absorbing constituent, and wherein a composition of the first energy absorbing constituent is different from a composition of the second energy absorbing 26 constituent.
27 31. The accommodating intraocular lens of claim 26, wherein the first haptic portion is radially 28 offset from the second haptic portion.
29 32. A method of adjusting an accommodating intraocular lens, comprising:
1 adjusting a base power of the accommodating intraocular lens by directing an external 2 energy at a composite material within at least one of an optic portion and a 3 peripheral portion of the accommodating intraocular lens, 4 wherein the composite material comprises an energy absorbing constituent and a plurality of expandable components.
6 33. The method of claim 32, further comprising adjusting the base power of the 7 accommodating intraocular lens when the accommodating intraocular lens is implanted 8 within an eye of a subject.
9 34. The method of claim 32, further comprising adjusting the cylindricity of an optical surface of an optic portion the accommodating intraocular lens by directing an external energy 11 at the composite material arranged at diametrically opposed peripheral edges of the 12 optic portion.
13 35. The method of claim 32, wherein the external energy is a laser light having a wavelength 14 between about 488 fun to about 650 nm 36. The method of claim 32, further comprising adjusting the base power of the optic portion 16 between about 0Ø5 D to about +Pi D by directing a pulse of the external energy at 17 the composite material.
18 37. The method of claim 32, wherein the optic portion comprises a fluid-filled optic chamber 19 and the peripheral portion comprises at least one haptic comprising a fluid-filled haptic fluid chamber in fluid communication with the optic chamber, wherein the method 21 further comprises directing the external energy at the composite material to displace 22 fluid between the optic chamber and the haptic fluid chamber.
23 38. The method of claim 32, further comprising adjusting the base power of the 24 accommodating intraocular lens by directing the external energy at the composite material to change a volume of the haptic fluid chamber.
26 39. The method of claim 32, further comprising adjusting the base power of the 27 accommodating intraocular lens by directing the external energy at the composite 28 material to change a volume of the optic fluid chamber.
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EP4041133A1 (en) | 2022-08-17 |
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CN114650789A (en) | 2022-06-21 |
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